Progress 09/01/10 to 08/31/14
Outputs
Target Audience: The biological impact study was conducted during the 2012–2013 school year (October 2012 to July 2013) with schoolchildren attending 12 World Vision schools in Muyinga province; this report covers the reporting period of September 1, 2010, to August 31, 2014. The first target audience for the biological impact study consisted of the students of World Vision schools receiving food aid from the World Food Program in rural Burundi. These children resided within Muyinga province in the Republic of Burundi. The disadvantages experienced by this population included limited access to high-quality health care services, food insecurity, poverty, and parental figures with low levels of literacy and very little health and hygiene knowledge. This study provided free hemoglobin testing and anemia diagnoses at each of the 12 biological impact study schools. Most families were unaware of this test, since it was not provided at local health centers, and they were also unlikely to be able to afford such a test at a regional hospital. This study therefore provided many families with high-quality health care free of charge. The second target audience was the food aid community, including the US Agency for International Development (USAID) and the US Department of Agriculture (USDA) and its various implementers. Before fortified rice could be added to the USDA food commodity list, longitudinal data first had to prove that the product had only minimal micronutrient losses and did not foster microbial growth during storage. The third target audience was the fortified rice research community, including members from Abbott Nutrition, ETH Zurich (Eidgenössische Technische Hochschule Zürich [Swiss Federal Institute of Technology Zurich]), IRD (L’Institut de Recherche Pour le Développement [Research Institute for Development), GAIN (Global Alliance for Improved Nutrition), and DSM (Royal DSM). The results of this clinical trial were combined with previous clinical trials to examine patterns in formulation (i.e., micronutrient composition) and clinical health outcomes; this data-sharing event took place during a stakeholders meeting held in Ethiopia prior to the Micronutrient Forum of June 2014. The outcome of this meeting has led to further research on formulation composition for enhanced effectiveness in iron status outcomes. Changes/Problems: This study was originally designed to assess the impact of consuming fortified rice on the Hb concentration and serum ferritin stores of schoolchildren in Burundi. To test the children’s blood samples for ferritin stores, costly ferritin enzyme-linked immunosorbent assay (ELISA) kits had to be procured and transported to Burundi through the complicated customs importation process, while ensuring the cold chain was maintained. A sufficient number of kits were purchased to process the blood samples collected at baseline, and two laboratories were hired to independently test 10% of the baseline samples; however, the two laboratories yielded very different results. A variety of factors likely contributed to the different results. For instance, the private laboratory had the most modern technologies, a consistent supply chain of reagents imported from Belgium, and a skilled hematologist to conduct the testing; the government laboratory (subcontracted by ISTEEBU) had older machines and was dependent on PATH to import the necessary reagents through Burundian customs. When the discrepant results were received, the government laboratory was instructed not to process the remaining 90% of the samples until the problem was corrected, but this instruction was not followed. In order to achieve accurate ferritin results, the team determined that an independent consultant would need to be hired and sent to Burundi to investigate the source of discordance. To hire a consultant and purchase replacement ferritin ELISA kits would have incurred prohibitive costs to the project, and ultimately the testing of iron stores had to be removed from the study protocol. This issue was discussed with USDA prior to making the final decision to omit ferritin testing. What opportunities for training and professional development has the project provided? Training Trainings were provided to the ISTEEBU data collectors during the months of October 2012 and June 2013. The ISTEEBU data collectors were previously trained in demographic data collection and administering surveys to the local population; however, none had prior experience collecting dietary diversity data. By the end of the trainings, each data collector was able to group foods together based on their nutritional content and dissect recipes to account for less obvious ingredients. Professional development opportunities A PhD candidate from the University of Washington was invited to intern with the Rice Fortification team at PATH and assist with data analysis. This collaborative relationship was cost-effective for the Rice Fortification team and provided a professional opportunity for a student within the University of Washington’s Epidemiology Department. This student excelled at the tasks requested of her and will likely be considered for future employment opportunities. The principal investigator of this study gained further experience at an international conference when presenting these results at the Micronutrient Forum Global Conference in June 2014. How have the results been disseminated to communities of interest? Dissemination of results to partners and stakeholders in Burundi PATH produced a PowerPoint presentation to disseminate the findings to the study’s steering committee, which included World Vision, the World Food Program, ISTEEBU, INSP, the MOH, and PRONIANUT. The results were discussed among the members of the steering committee on September 26–27, 2013 in Bujumbura, and edits were made to the slides prior to dissemination at the national level. Following approval by the steering committee, a larger dissemination event was held on September 30, 2013, in Bujumbura to inform the greater humanitarian aid community within Burundi of the study’s findings. Attendees of the larger dissemination event included the steering committee, WHO, the Ministry of Education, USAID, Institute of Agricultural Science of Burundi (ISABU), East Africa Regional Office Food Programming and Management Group (EARO FPMG), and the EARO Nutrition Learning Center. Dissemination of results to parents Following data analysis, the PATH study team summarized the results using simple language and images to ensure parents understood that there was no difference in hemoglobin improvement and anemia reduction between the schoolchildren who received a fortified school lunch and those who received a non-fortified school lunch. World Vision invited the study participants’ parents to small workshops within their commune. The study results were presented to the school headmasters, parents, and other technical services representatives, and they were discussed in detail to ensure all attendees understood the results. These community dissemination events were held at the end of September in Muyinga province. Further dissemination efforts were conducted at each school, led by the school’s headmaster and a World Vision schools’ monitor, to ensure the parents who failed to attend the commune-level workshops were also informed. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Objective 1: An acceptability study of fortified rice among beneficiaries of the FANEP Ultra Rice (UR) fortification project in Gasorwe Commune, Muyinga Province, Burundi The objective of this study was to test whether the local community could differentiate between fortified rice and milled rice based on appearance, taste, and smell. To assess acceptance, parents and children from the Gasorwe Commune were asked to compare fortified and milled rice. This was done through the triangle test method, whereby each participant sampled three numbered plates of rice; two of them contained unfortified rice and one, fortified rice. Participants completed a questionnaire to assess whether they could differentiate between the two varieties based on appearance, smell, and taste. Fortified rice was widely accepted among participants. The majority could not see (78%), taste (94%), or smell (98%) any difference. Key outcome: Participants learned about fortified rice, accepted it and expressed willingness to consume it. Objective 2: The incremental cost of adding fortified grains to school feeding programs This analysis assessed the affordability of rice fortification in a real-life food aid context to support the USDA approval of fortified rice as a commodity available to McGovern-Dole and Title II programs globally by addressing two questions: 1. What is the incremental cost to fortify a school meal program with rice? 2. What is the incremental cost per child, per school year, to fortify a school meal program with rice? With the assistance of WVB and WFP, PATH implemented a SMP with fortified rice during the 2012–2013 school year. The programmatic baseline costs and the incremental costs of fortification are defined in a cost brief developed by the team and submitted to USDA and are based on a program serving 3,938 schoolchildren for one school year. Results Total baseline costs for WV to operate their school meal program in rural Burundi were $214,035 USD, averaging $54.35 USD per child per school year. The purchase and transport of milled rice from local markets cost approximately $905 USD per MT. The (annualized) costs required to initiate a rice fortification program (i.e., equipment, training, etc.) approximated $5,121 USD while the costs associated with maintaining such a program after initiation were $18,103 USD, annually. The incremental cost of adding UR fortified grains to the regular school meal was an additional $5.90 USD per child per school year. Initial start-up costs would inflate programmatic costs by about one-tenth (10.9%); annual ongoing costs thereafter would increase the baseline cost by less than one-tenth (8.5%). Since fortified rice was recently added to the USDA food-aid commodity list, this exercise was an important first step in determining actual costs of incorporating fortified rice into programs. Objective 3: The stability of UR under real-world transport and storage Samples of UR fortified grains and the milled rice were obtained from the WVB warehouse and sent to the Silliker Canada Co. laboratory for moisture, micronutrient, and microbial testing. Tests were conducted every 6 months to document vitamin stability and ensure the product was fit for consumption. Moisture was tested using a gravity-convection oven. Levels of iron, zinc, thiamine, and folic acid were determined using inductively coupled plasma spectroscopy. Microbe counts were conducted for aerobic colony count, Bacillus cereus, E. coli, Salmonella, yeast and mold. After 30 months of storage, losses of iron (12%), zinc (14%), thiamine (10%), and folic acid (8%) from the fortified grains were less than 20%. This indicates that a 20% overage in the initial micronutrient premix is required to guard against micronutrient losses. The microbiological growth counts in the fortified grains were below the WFP limits at 30 months; Salmonella tests were negative at every time point. This shows fortified grains are safe for consumption after 30 months of storage, suggesting the shelf life for fortified grains can be extended to 24 months in similar climates. A shelf-life extension to 2 years significantly increases the product’s value for both the public and private sectors. For fortified rice, microbiological growth counts were undetectable until 12 months. Salmonella tests were negative at every time point. The presence of UR kernels did not indicate any signs of fostering microbial growth when combined with milled rice. Fortified rice is likely to be safe for consumption after 12 months of storage. Objective 4: The homogeneity of the blended, fortified product The study team established blending operations at the WVB warehouse, where a Toshniwal mixing unit was installed. The WVB warehouse staff were trained to operate the blending machine, conduct quality control tests on the blended product, and repackage the fortified rice for transport to schools. To blend, the team weighed out pre-specified quantities of UR fortified grains according to the optimal batch size to achieve a 1:100 blend ratio. These fortified grains were then mixed with milled rice to create a homogenous blend. Homogeneity (QA) testing was carried out by taking 100-g samples of fortified rice from the repackaged product and testing them to ensure that the blend ratio fell within a 20% coefficient of variation (COV) of the 1:100 blend ratio. Homogeneity tests were conducted on bags stored in the warehouse every 6 months over a period of 24 months to determine if storage affected blend homogeneity. The blend ratio was also evaluated at three schools to determine if transportation influenced blend homogeneity. Key outcome: The Toshniwal blender consistently produced the desired 1:100 blend ratio, allowing for a 20% COV. The homogeneity testing revealed that long-term storage up to 24 months did not affect that ratio. Long-distance transportation to remote schools over unpaved roads also did not affect the 1:100 ratio. Objective 5: The biological impact among children who consume fortified rice To assess the health impact of UR in African schoolchildren, specifically on Hb levels and anemia status, PATH conducted a biological health impact study completed at the end of the 2012–2013 school year. About 7,400 children received school lunches, and 1.5 MT of fortified grains were mixed and delivered. Milled rice was delivered to six schools (control group) and the UR mix to six schools (intervention group). All of the 1,071 children enrolled in the study had mild or moderate anemia at baseline; the severity of anemia was greater among the intervention schoolchildren. Of the initial number tested, 904 children were followed up at endline. The team observed similarly significant health improvements among the control and intervention schools after the 7-month study period. The proportion of enrolled children who were anemic fell from 100% at baseline to 45% and 47% in the intervention and control groups (p > 0.05). While hemoglobin levels increased more among the children in the intervention group, the difference between the two groups was not statistically significant (β = 0.085 g/dl; 95% CI: -0.21–0.38; p > 0.05). The team hypothesized that the similar response in both arms was related to high rates of food insecurity, high rates of infection, and a possible micronutrient interaction between iron and zinc. Key learnings: Rice fortified with iron, zinc, thiamine, and folic acid did not significantly improve hemoglobin concentrations or anemia prevalence among anemic Burundian schoolchildren. The traditional diet of maize, cassava, beans, groundnuts, leafy greens, and bananas is unlikely to provide sufficient quantities of vitamin A, vitamin C, riboflavin, and B12 to support iron absorption and utilization of iron for hemoglobin synthesis. Fever within 2 weeks prior to data collection resulted in lower hemoglobin concentrations and a lower likelihood of improvement in anemia status.
Publications
- Type:
Journal Articles
Status:
Other
Year Published:
2015
Citation:
Parker, Megan et al. A blinded, cluster-randomized, placebo-controlled school feeding trial in Burundi using rice fortified with iron, zinc, thiamine, and folic acid. (Currently unpublished)
- Type:
Other
Status:
Published
Year Published:
2014
Citation:
Two abstracts at the Micronutrient Forum conference (Ethiopia, June 2014) and both were accepted for poster presentation. These two abstracts, along with all the accepted conference abstracts, were compiled into one booklet for dissemination to the participants.
Tripathi, Rahul, Parker, Megan et al. Ultra Rice� technology: acceptable micronutrient losses and limited microbial growth enable shelf life extension Micronutrient Forum, Addis Ababa, Ethiopia. June 2014.
Parker, Megan et al. Treatment of anemia with iron-fortified rice in a school lunch program in Burundi Micronutrient Forum, Addis Ababa, Ethiopia. June 2014.
- Type:
Other
Status:
Published
Year Published:
2014
Citation:
Two posters at the Micronutrient Forum, June 2014
Tripathi, Rahul, Parker, Megan et al. Ultra Rice� technology: acceptable micronutrient losses and limited microbial growth enable shelf life extension Micronutrient Forum, Addis Ababa, Ethiopia. June 2014.
Parker, Megan et al. Treatment of anemia with iron-fortified rice in a school lunch program in Burundi Micronutrient Forum, Addis Ababa, Ethiopia. June 2014.
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Progress 09/01/12 to 08/31/13
Outputs
Target Audience: The biological impact study was conducted during the 2012-2013 school year (October 2012 to July 2013) with schoolchildren attending 12 World Vision schools in Muyinga province; this report covers the reporting period of September 1, 2012 to August 31, 2013. The first target audience, for the biological impact study, was the students of World Vision schools receiving food aid from the World Food Program in rural Burundi. These children resided within Muyinga province in the Republic of Burundi. The disadvantages experienced by this population included limited access to high-quality health care services, food insecurity, poverty, and parental figures with low levels of literacy and very little health and hygiene knowledge. This study provided free hemoglobin testing and anemia diagnoses at each of the 12 biological impact study schools. While most families were unaware of this test, since it was not provided at local health centers, they were also unlikely to be able to afford such a test at a regional hospital. This study therefore provided many families with high-quality health care free of charge. The second target audience was the food aid community, including the US Agency for International Development (USAID) and the US Department of Agriculture and its various implementers. Before fortified rice can be added to the USDA food commodity list, longitudinal data must first prove that the product has only minimal micronutrient losses and does not foster microbial growth during storage. Changes/Problems: This study was originally designed to assess the impact of consuming fortified rice on the hemoglobin levels and serum ferritin stores of schoolchildren in Burundi. To test the children’s blood samples for ferritin stores, costly ferritin enzyme-linked immunosorbent assay (ELISA) kits had to be procured and transported to Burundi through the complicated customs importation process, while ensuring the cold chain was maintained. A sufficient number of kits were purchased to process the blood samples collected at baseline, and two laboratories were hired to independently test 10% of the baseline samples; however, the two laboratories yielded very different results. A variety of factors likely contributed to the different results. For instance, the private laboratory had the most modern technologies, a consistent supply chain of reagents imported from Belgium, and a skilled hematologist to conduct the testing; the government laboratory (subcontracted by ISTEEBU) had older machines and was dependent on PATH to import the necessary reagents through Burundian customs. When the discrepant results were received, the government laboratory was instructed not to process the remaining 90% of the samples until the problem was corrected, but this instruction was not followed. In order to achieve accurate ferritin results, the team determined that an independent consultant would need to be hired and sent to Burundi to investigate the source of discordance. To hire a consultant and purchase replacement ferritin ELISA kits would have incurred large costs to the project, and ultimately the testing of iron stores had to be removed from the study protocol. What opportunities for training and professional development has the project provided? Training Trainings were provided to the ISTEEBU data collectors during the months of October 2012 and June 2013. The ISTEEBU data collectors were previously trained in demographic data collection and administering surveys to the local population; however, none had prior experience collecting dietary diversity data. By the end of the trainings, each data collector was able to group foods together based on their nutritional content and dissect recipes to account for less obvious ingredients. Professional development opportunities A PhD candidate from the University of Washington was invited to intern with the Rice Fortification team at PATH and assist with data analysis. This collaborative relationship was cost-effective for the Rice Fortification team and provided a professional opportunity for a student within the University of Washington’s Epidemiology Department. This student excelled at the tasks requested of her and will likely be contacted for future employment opportunities. The principal investigator of this study will gain further experience at an international conference when presenting these results at the Micronutrient Forum Global Conference in June 2014. How have the results been disseminated to communities of interest? Dissemination of results to partners and stakeholders in Burundi PATH produced a PowerPoint presentation to disseminate the findings to the study’s steering committee, which included World Vision, the World Food Program, ISTEEBU, INSP, MOH, and PRONIANUT. The results were discussed among the members of the steering committee on September 26–27 in Bujumbura, and edits were made to the slides prior to dissemination at the national level. Following approval by the steering committee, a larger dissemination was held on September 30, 2013, in Bujumbura to inform the greater humanitarian aid community within Burundi of the study’s findings. Attendees of the larger dissemination event included the steering committee, the World Health Organization, the Ministry of Education, USAID, ISABU, EARO FPMG, and the EARO Nutrition Learning Center. Dissemination of results to parents Following data analysis, the PATH study team summarized the results using simple language and images to ensure parents understood that there was no difference in hemoglobin improvement and anemia reduction between the schoolchildren who received a fortified school lunch and those who received a non-fortified school lunch. World Vision invited the study participants’ parents to small workshops within their commune. The study results were presented to the school headmasters, parents, and other technical services representatives, and they were discussed in detail to ensure all attendees understood. These community dissemination events were held at the end of September in Muyinga province. Further dissemination efforts were conducted at each school, led by the school’s headmaster and a World Vision schools’ monitor, to ensure the parents who failed to attend the commune-level workshops were also informed. What do you plan to do during the next reporting period to accomplish the goals? During the next reporting period, the study team plans to publish a paper documenting the biological study findings in a peer-reviewed journal. Certain aspects of the operational study will be included in the biological study paper. An abstract of this paper will be submitted to the Micronutrient Forum to be considered for presentation at the June 2014 conference in Ethiopia. A cost-effectiveness brief will be developed independently to explain the incremental costs of adding Ultra Rice® premix kernels to a rice-based school lunch program. All of the results will also be presented to the USDA prior to the study’s end date.
Impacts
What was accomplished under these goals?
The project’s primary objectives included (1) generating operational data on the stability of Ultra Rice® fortified grains under real-world transport and storage conditions (the Ultra Rice® technology has previously only been studied under laboratory conditions) and (2) assessing the health impact of Ultra Rice® in African schoolchildren, specifically on hemoglobin levels and anemia status. Objective 1 To achieve the first objective, the study team generated operational data on the ability of Ultra Rice® fortified grains to withstand the challenging climate and storage conditions present in Burundi and many parts of Africa. To do this, microbiological and micronutrient tests were conducted every six months between June 2011 and June 2013. The data showed that both the growth of bacteria and loss of vitamins and minerals were small and within acceptable limits. This analysis also showed that the blending ratio was consistently maintained. These data are contributing to the rice fortification team’s growing body of evidence on expected micronutrient losses over time in various climates and conditions. Importantly, the data also contributed to the extension of the product’s expected shelf life, thereby supporting its inclusion on the USDA food aid commodity list. The current industry standard sets the product’s expiration date at 12 months. By documenting that the grains are still safe for consumption at 30 months (final tests will be carried out in November 2013), PATH can extend the expected shelf life of Ultra Rice® grains to 24 months. A shelf-life extension to two years will significantly increase the product’s value for both the public and private sectors. Objective 2 To assess the health impact of Ultra Rice® in African schoolchildren, specifically on hemoglobin levels and anemia status, PATH conducted a biological health impact study that was completed at the end of the 2012–2013 school year. During the study, approximately 7,400 children received school lunches, and 1.5 metric tons of Ultra Rice® fortified grains were mixed and delivered. Traditional rice was delivered to six schools (control group) and the Ultra Rice® mix to six schools (intervention group). All of the 1,071 children enrolled in the study had mild or moderate anemia at baseline; however, the severity of anemia was greater among the intervention schoolchildren. Of the initial number tested, 904 children were followed up at endline, representing an impressive 84% retention rate. The study team observed significant health improvements among both the control and intervention schools after the seven-month study period. The proportion of enrolled children who were anemic fell from 100% to 40% overall at endline data collection. While our analysis found that hemoglobin levels increased more among the children in the intervention group, the difference between the intervention and control groups was not statistically significant. The study team hypothesized that the similar response to the program in both study arms was related to high rates of food insecurity in the area, high rates of infection, and a possible micronutrient interaction between iron and zinc. First, due to the high rates of food insecurity, many schoolchildren were not receiving regular meals in their homes, and thus the consumption of the school lunch—with or without the extra micronutrients—had a significant impact on their health. From the field it was reported that some children chose not to eat their full lunch ration, instead taking half of it home to feed their family. Second, a substantial number of children experienced febrile illness (illness accompanied by fever) within two weeks prior to baseline (~50%) and endline (~50%). Febrile illness was directly related to lower hemoglobin levels; children with a recent fever were twice as likely not to improve in anemia status. According to the scientific literature, it is possible that the high incidence of illness may have decreased the children’s ability to absorb dietary iron and signaled iron in the blood to return to the body’s iron stores. With these results, the study team recognizes that future anemia interventions in similar settings cannot only include a dietary component but should be more comprehensive in nature (i.e., distribute bed nets, determine if the cause of anemia is non-dietary at baseline). Last, although there is no strong evidence yet to discourage joint supplementation with iron and zinc, some trials have shown that joint supplementation has less of an effect on biochemical or functional outcomes than does supplementation with both minerals given separately. Previous studies feeding fortified rice to improve hemoglobin status have produced mixed results, while ferritin levels have always improved. The study team now believes that a greater iron-to-zinc molar ratio may be needed to significantly increase hemoglobin and is working with Abbott Nutrition toward isolating the minimum ratio necessary using both in vitro and in vivo studies.
Publications
|
Progress 09/01/11 to 08/31/12
Outputs
OUTPUTS: In the 12 months covered by this report, project activities were focused on establishing local blending operations to provide fortified rice through the World Vision school feeding program in Muyinga; testing homogeneity and stability of fortified rice; and preparing for the biological impact study. Principal outputs during this period were: Operational Trial: - The Forberg blender was purchased, shipped from India, and installed in the World Vision Muyinga warehouse. Blending operations were established in October 2011. - Homogeneity was found to be acceptable and consistent using the Forberg blender, and before and after transit from the warehouse to the schools. - The secondary manual blender, selected and procured by WVB for comparison trials with the Forberg blender, was determined to be unsuitable for the purpose of rice fortification once trials were initiated in the warehouse. The fortified grains fell out of valves in the machine rather than blending with the rice, so homogeneity data was not collected. Due to the high performance of the Forberg blender, the lack of a viable second blender will not impact the ability of World Vision or WFP to replicate rice fortification activities in other warehouse settings. - Fortified rice was fed to approximately 13,000 school children in 20 schools in WV's Muyinga school feeding program for a portion of the school year (timeframe depending on the school). - Samples of Ultra Rice were pulled from the warehouse in June 2012 (one year after grain production) and analyzed for stability by Silliker Laboratories in Canada. There were no significant losses in nutrient levels, and microbiological content was found acceptable. Real-world stability testing will continue for 24 months. Biological Trial - Delays in preparing for the biological trial in the school year 2011-2012, postponed the study (please refer to the Project Modifications section for further detail). - PATH received approval for the study protocol from PATH's Research Ethics Committee (REC) in August 2012. Note: A subsequent protocol modification was approved in October 2012. - In July 2012, the Burundi Ethics Committee extended their approval of the study through December 2013. Note: A subsequent protocol modification was approved in October 2012. - The contractual relationship with Ifakara Health Institute (IHI) in Tanzania was effectively terminated in May 2012 in order to restructure the project for more streamlined implementation. Note: Contract termination was officially signed September 2012. - A contract directly between PATH and the Burundi research organization ISTEEBU (Institute of Statistics and Economic Studies) was signed in June 2012. - Study supplies were procured for the biological study from distributors in the USA and Burundi in August-September 2012. - Study materials and curricula were developed to train the study team in August-September 2012. - A new batch of Ultra Rice grains was produced in Brazil and ready for shipment as of 8/31/12. Note: Due to a strike by Brazilian postal workers, grains were not shipped until October 2012. PARTICIPANTS: Personnel: Dr. Megan Parker, engaged in May 2012 as a consultant to provide in-country coordination of the biological study, was subsequently hired by PATH in August 2012 to assume the combined role of Co-Project Director and Principal Investigator. With approval from USDA, senior project manager Matthew Frey, co-Project Director Deepali Hariprasad and Principal Investigator Kiersten Israel-Ballard moved on to other projects within PATH. PATH technical officer Deshraj Sharma traveled from Delhi to Burundi in October 2011 to establish blending operations in World Vision's Muyinga warehouse and train WVB staff and provided support to the operational trial. Additional hires for the project were Melody Waring as program assistant, Nissa Limbach as project administrator (replacing Toni Lindquist in March, 2012), and consultant Sandra Lennon for interim project management support. The World Vision project manager assigned to the project also changed in the fall of 2011, to Marta Perez. Partners: While redesigning the launch of the biological study, PATH decided to remove IHI as CRO and to contract directly with ISTEEBU to simplify contracting and communication among partners. PATH continued to lead virtual project management conferences with partners on a weekly or bi-weekly basis. Dr. Kiersten Israel-Ballard and consultant Sandra Lennon traveled to Washington, DC, in May 2012 to meet with ISTEEBU, WV, and USDA-FANEP staff to re-establish partners' commitment to the project and review ISTEEBU's scope of work. Six casual laborers and four permanent World Vision Burundi (WVB) staff were trained on blender operations by PATH technical staff. World Vision committed additional co-funding through the life of the project (WV's own operating costs and an additional year of subsidy to the school feeding program). Delays occurred in negotiating a revised scope of work for a no-cost extension of WV's subcontract with PATH, including financial responsibility for purchase and shipment of a new batch of Ultra Rice grain for the biological study, since grain remaining in the Muyinga warehouse was past its manufacturer's expiration date. Ultimately, PATH assumed this cost in order for the grain to be produced and shipped in time for the biological study. The World Food Programme committed to providing rice for WV's school feeding program for the academic year 2012-2013. The Burundi Ministry of Health continues to be supportive of the biological impact assessment. The National Ethics Committee of Burundi renewed its approval of the study through December 2013. TARGET AUDIENCES: Dipika Matthias, director of the Ultra Rice project, and other PATH staff participated in the annual USDA-USAID Food Aid Conference in Kansas City May 7-9, 2012. PATH had a display table and Dipika gave a presentation within the "New Product Development, Field Trials, and Pilot Projects" panel session. Paul Alberghine, PATH's contract officer at USDA-FAS, moderated the discussion and was active in getting information about PATH's work out to conference participants. Participation in the conference contributed to further visibility of the Ultra Rice technology and rice fortification in the food aid community, which represents a key target audience for this project. PROJECT MODIFICATIONS: Operational Study: PATH continued to experience the challenges of working remotely with partners in Burundi. There were delays in performing planned testing of the fortified rice in the Muyinga warehouse, and new grains were procured for the 2012-2013 biological impact study. The overall schedule for stability and homogeneity testing through the end of the project has been modified accordingly, maintaining the plan of tests on regular 6-month intervals, but with the new grain. Biological Study: Extensive delays in obtaining PATH and Burundian government ethical review board approvals in the 2011-2012 school year, along with delays in finalizing contracts between PATH/IHI, and IHI/ISTEEBU (partly due to protracted budget negotiations between partners to contain study costs given budget constraints), left insufficient time in the school year to conduct a scientifically valid trial. As a result, PATH decided in February to postpone the study to the 2012-2013 school year. With much of the groundwork laid, PATH, USDA-FANEP, World Vision, and the World Food Programme committed to re-launching the biological study. To address challenges with partner coordination and communication, PATH disengaged from its relationship with IHI and subcontracted with ISTEEBU directly to carry out the study. Two changes were made to the study protocol based on information from the field (the approved protocol was sent for USDA's review and approval in September, 2012): Since children living in the countryside of Burundi do not enter school until age 7, and there was concern that the study age range of 6-9 would not allow for enough eligible study participants, the age range was changed to 7-11. Secondly, at the request of ISTEEBU, PATH eliminated any compensation to study participants, as this is generally not done in Burundi and would set a difficult precedent for future studies.
Impacts
There are no significant outcomes to report during this reporting period.
Publications
- No publications reported this period
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Progress 09/01/10 to 08/31/11
Outputs
OUTPUTS: Project Inception Phase: 10/10-1/11: The initial four months of the project were dedicated to a range of startup activities so as to lay a successful foundation for project implementation. Principal outputs during this period: - Joint PATH-World Vision (WV) press release issued and four news stories written about the project by various on line news services. - Secured WV engagement early on in the project with the issuance of a Pre-Award Letter followed by a subagreement. - Convened national and provincial stakeholder meetings in Burundi to introduce the project and consult with key institutions. From these meetings emerged affirmation of the feasibility of the biological trial, support from key partners such as the Ministry of Health (MOH) and World Food Program (WFP), and endorsement of the proposed micronutrient content of the Ultra Rice premix grains. - Tripartite project agreement signed between project partners WFP, WV, and Min. of Ed. granting government approval for the project (subject to MOH approval of Ultra Rice product for use in Burundi). - Creation of three virtual working groups to facilitate participation of key partners in overall project management and to guide the technical work undertaken in the operational and biological trial arms of the project, respectively. Scope of work for CRO (clinical research organization) developed. - CRO IFAKARA (IHI from Tanzania) and local research organization ISTEEBU (research institute of the Ministry of Planning) selected through a competitive bidding process. Project White Paper developed and distributed for US Ambassador and Burundi Minister of Health project introduction. Project Field Trial Preparation Phase: February-August 2011: With all project partners on board and fully staffed, the project shifted its focus to preparation for the biological and operational field trials to be carried out in year 2. The following are principal outputs for this 7-month period: 1. Operational Trial: - Ultra Rice premix grains procured, shipped, and in place in Muyinga for trial startup. Samples were tested for safety and nutrient content by both PATH's independent laboratory and by a Burundian national food laboratory and approved for human consumption. - Semi-automatic (Forberg) and batch (ribbon) blenders procured. Shipping and installation delayed until October and November 2011, respectively. - A fortified rice acceptability trial was conducted by WV in Muyinga using a trial protocol provided by PATH. The trial indicated that fortified rice was entirely acceptable from a sensory perspective to a representative group from two Muyinga school communities. - Operational trial protocol developed, including stability and nutrient retention testing, blending validation, and incremental cost analysis for rice fortification. 2. Biological trial: - Biological impact study protocol finalized. - PATH Ethics Committee application submitted (twice) for biological impact study and conditional approval obtained (subject to final Burundi approvals). - Contracts with IHI and ISTEEBU negotiated but not yet signed. - Burundi project steering committee formed and convened by MOH Director General. PARTICIPANTS: 1. Personnel: A challenge faced by the project has been changes in personnel at PATH and WV. PATH has had two investigator changes for the biological trial, creating delays in protocol finalization and challenges for PATH's IRB review process, and disrupting continuity of the work. Two members of WV's key project personnel were not available soon after launch: the Food Program Advisor and Senior Food Aid Officer. However, the project is currently fully staffed with able and motivated personnel. 2. Institutional Partners: PATH has worked to establish strong institutional partnerships with various stakeholders both through the establishment of virtual working groups that meet regularly, and trips to Burundi and Tanzania. PATH personnel have conducted three trips to East Africa during year 1 to meet partners, advancing planning and preparation for trials. Project partners have shown a high degree of commitment to successful project outcomes. One indicator of this has been willingness to contribute non-project financial resources to fill gaps created by reductions in the originally proposed budget, made by USDA at time of award ($400,000). WV contributed roughly $100,000 of private resources to enable the school feeding program to be conducted in Muyinga, as it faced WFP budget cuts but is essential to project feasibility. WV also agreed to transfer $30,000 of its original approved budget to PATH and IHI, PATH's clinical research organization, to support costs of the biological trial. IHI likewise offered $56,000 in co-funding for its personnel and travel costs to make the biological trial possible. WFP has contributed all rice grain for the project and committed funding for WV's school feeding program. At the government level, the MOH has shown steady interest and support in this rice fortification effort, first through the Minister of Health's approval of the project and designation of counterparts for PATH and WV to work with (Nutrition and Food Security Institute Director, Dr. Gilbert) and later through the appointment of an MOH-led project steering committee presided over by the Director General himself. ISTEEBU is the local research organization selected to collect and enter data and oversee government approvals. ISTEEBU has proven difficult to work with, raising last-minute budget requirements on several occasions and being unresponsive to IHI and PATH, thus casting doubt on the viability of the biological field trial. ISTEEBU's managerial limitations and uncertain commitment to the research were in evidence early on, but the MOH counseled against using another firm due to the special mandate enjoyed by ISTEEBU to conduct clinical research of this nature. PATH and WV are working closely to manage this situation to a successful outcome by making additional missions to Burundi in the Fall and by seeking MOH assistance to help negotiate with ISTEEBU. TARGET AUDIENCES: The Project Manager participated in the annual USDA-USAID Food Aid Conference in Kansas City. Considerable networking was done at the conference, both informally and through a PATH display table. This attention served to heighten the visibility and interest level in Ultra Rice and in our Burundi trial amongst various members of the food aid community, a key target audience for this project. PATH looks forward to formally presenting project trial results at the 2012 Food Aid Conference. PROJECT MODIFICATIONS: The difficulty of advancing project work "remotely" in the Burundi context grew increasingly clear over the course of year 1 and prompted a decision to enhance the in- country presence of the project manager through more frequent travel. An April trip served to clarify the role of the government in trial approvals and monitoring and established a clear process for project launch. Efforts were made to identify a Burundi-based consultant who could be hired to help the team overcome implementation barriers with ISTEEBU and local government, but no suitable candidates were found. Considerable delays were experienced in various facets of the project. Procurement, manufacture, and shipment of Ultra Rice premix and of blending equipment were delayed at each stage in the process. While the team was able to surmount each obstacle, these delays contributed to delays in the launch of the trials, which resulted in considerably lower expenditure rates during year 1 than anticipated. Difficulties in finalizing the study design with ISTEEBU and reaching agreement on the final biological study budget have proven highly challenging to overcome despite concerted efforts from PATH, WV, and IHI. Without full consensus on study design and related implementation costs, PATH has been unable to sign a contract with IHI and between IHI and ISTEEBU. Consequently, the biological trial launch preparation that should have been completed in year 1 of the project is still pending. This delay has further slowed budget expenditures and may compel PATH to explore the feasibility of delaying the biological trial until the 2012-13 school year. Assuming that PATH and its partners are successful in completing the negotiations with ISTEEBU and obtaining government approvals in time to conduct the study this school year, project expenditure rates will accelerate rapidly. With operational trial activities beginning in Fall 2011, WV expenditure rates will also increase dramatically in year 2. PATH anticipates that the year 2 burn rate will increase significantly. Demographic and Health Survey data was released in early 2011 that revealed a drop in anemia rates in Burundi from the previously available data used to calculate sample size and budget in the project proposal submission. As a result, the study's sample size had to be increased considerably in order to maintain a powerful study design. This change compelled PATH to shift additional resources from the operational trial and from PATH's own direct cost budget to the biological trial and necessitated financial contributions from both WV and IHI. NIFA was consulted about these changes and is informed and appreciative of the commitment and flexibility demonstrated by implementing partners.
Impacts
Nothing significant to report during this reporting period.
Publications
- USDA grants PATH, World Vision $1 million to fortify food aid in Burundi [press release]. Seattle: PATH; October 20, 2010. Available online at: http://www.path.org/news/pr101020-ultra-rice-burundi.php
- Burundi: Fortified rice for 15,000 school-children. IRIN News. January 5, 2011. Available online at: http://irinnews.org/Report.aspxReportID=91529
- Timmerman L. PATH Snags $1M Federal Grant to Take Ultra Rice to Africa. Xconomy: Seattle. October 20, 2010. Available online at: http://www.xconomy.com/seattle/2010/10/20/path-snags-1m-federal-grant -to-take-ultra-rice-to-africa/
- Gharib, M. Ultra Rice makes its official debut in Africa. One Blog. October 21, 2010. Available online at: http://www.one.org/blog/2010/10/21/ultra-rice-makes-its-official-debu t-in-africa/
- Schwartz, A. PATH Bringing Super-Fortified Rice to Africa. Fast Company. Oct 19, 2010. Available online at: http://www.fastcompany.com/1696459/path-bringing-fortified-rice-to-af rica
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