A Blinded, Cluster-Randomized, Placebo-Controlled School FeedingTrial in Burundi Using Rice Fortified With Iron, Zinc, Thiamine, and Folic Acid.

BACKGROUND: Iron-deficiency anemia is a major public health problem among school-aged children in sub-Saharan Africa. OBJECTIVE: To evaluate the effectiveness of micronutrient-fortified rice to increase hemoglobin (Hb) concentration and reduce the prevalence of anemia among schoolchildren. METHODS: Nine hundred four schoolchildren participated in this cluster-randomized trial during a 7-month intervention period. The study was conducted in 12 primary schools in rural Burundi. Hemoglobin, socioeconomic status, febrile illness, and dietary diversity were measured at baseline and follow-up. The changes in Hb concentration and anemia status were analyzed using linear and logistic mixed models, respectively. The micronutrient formulation contained an iron-to-zinc molar ratio of approximately 2.2. RESULTS: There was no significant difference in Hb concentration between the intervention and control groups (ß = .09 g/dL; 95% confidence interval: -0.21 to 0.38) following the 7-month intervention. Nearly half the children reported having a fever within 2 weeks prior to baseline or follow-up. Children with febrile illness preceding follow-up were less than half as likely to show improvement in anemia status (odds ratio = 0.47, P < .001), with an average 0.56 g/dL smaller improvement in Hb at follow-up (P < .001). CONCLUSION: The high prevalence of fever and low iron-to-zinc molar ratio of the Ultra Rice formulation may have contributed to the lack of improvement in Hb. Alternatively, the detected anemia may not have been due to nutrient deficiencies. Anemia interventions in Burundi should implement multiple strategies to eliminate both iron deficiency and infectious causes of anemia.

Rice fortification: an emerging opportunity to contribute to the elimination of vitamin and mineral deficiency worldwide.

Vitamin and mineral deficiencies are ranked among the top causes of poor health and disability in the world. These deficiencies damage developing brains, impair learning ability, increase susceptibility to infections, and reduce the work productivity of nations. Food fortification is a sustainable, cost-effective approach to reducing vitamin and mineral deficiency. As the staple food for an estimated 3 billion people, rice has the potential to fill an obvious gap in current fortification programs. In recent years, new technologies have produced fortified rice kernels that are efficacious in reducing vitamin and mineral deficiency. There are opportunities to fortify a significant share of rice that comes from large mills supplying centralized markets and national welfare programs in major rice-growing countries. The rice export markets, which handle 30 million MT of rice annually, also present a key fortification opportunity. The cost of fortifying rice is only 1.5% to 3% of the current retail price of rice. Countries that mandate rice fortification have the strongest evidence for achieving wide coverage and impact. The Rice Fortification Resource Group (RiFoRG), a global network of public and private partners that offers technical and advocacy support for rice fortification, has a vision of promoting rice fortification worldwide. It has a targeted approach, engaging multisector partners in key countries where the opportunities are greatest and there is receptivity to early adoption of large-scale rice fortification. The challenges are real, the imperative to address them is powerful, and the opportunities to deliver the promise of rice fortification are clear.

The Role of Multiply-Fortified Table Salt and Bouillon in Food Systems Transformation.

Our global food system lacks the critically needed micronutrients to meet the daily requirements of the most at-risk populations. Diets also continue to shift toward unhealthy foods, including the increased intake of salt. While most countries exceed the WHO's recommended levels, sodium does play an essential physiological role. Table salt and other salt-containing condiments, such as bouillon, also have cultural importance, as they are used to enhance the flavor of foods cooked at home. Given their universal consumption across income classes and both urban and rural populations, these condiments are an integral part of the food system and should, therefore, be part of its transformation. Fortification of salt and salt-containing condiments can play a catalytic role in the delivery of population-wide nutritional and health benefits. With relatively consistent levels of intake across the population, these condiments hold high potential for delivering micronutrients beyond iodine while also reducing concerns related to high micronutrient intake, particularly so in countries where the industries are relatively consolidated. As a flexible and complementary strategy to an evolving food system, fortification levels can also be adjusted over time to ensure micronutrient delivery targets continue to be achieved as the system improves, whether through lower intakes of sodium in line with WHO recommendations, enhanced consumption of nutrient-dense foods, and/or broader adoption of biofortified crops. Future areas of innovation are required to realize this vision, including developing affordable salt substitutes to meet cost requirements of consumers in low-and middle-income countries, improving the stability and bioavailability of the micronutrients in condiments so that delivery targets can be reached without affecting sensory attributes, and the development of efficient systems for monitoring population intake and micronutrient status to inform fortification program design and management. Rather than being considered antithetical to the transformation, multiply-fortified salt and bouillon can strengthen our ability to meet the cultural, sensory, nutritional, and health needs of an evolving food system.

Local markets for global health technologies: lessons learned from advancing 6 new products.

Key components to support local institutional and consumer markets are: supply chain, finance, clinical use, and consumer use. Key lessons learned: (1) Build supply and demand simultaneously. (2) Support a lead organization to drive the introduction process. (3) Plan for scale up from the start. (4) Profitability for the private sector is an absolute.

Rice fortification: a comparative analysis in mandated settings.

Legal mandates can play an important role in the success of rice fortification programs that involve the private sector. However, merely enacting mandatory legislation does not guarantee success; it requires a coordinated, multidimensional cross-sector effort that addresses stewardship, develops an appropriate rice fortification technology, enables sustainable production and distribution channels through a range of private-sector players, ensures quality, generates consumer demand, and monitors progress. Furthermore, economic sustainability must be built into the supply chain and distribution network to enable the program to outlast government administrations and/or time-limited funding. Hence, mandates can serve as valuable long-term enablers of cross-sector mobilization and collaboration and as catalysts of civil society engagement in and ownership of fortification programs. This paper compares the rice fortification experiences of Costa Rica and the Philippines--two countries with mandates, yet distinctly different industry landscapes. Costa Rica has achieved national success through strong government stewardship and active market development--key elements of success regardless of industry structure. With a comparatively more diffuse rice industry structure, the Philippines has also had success in limited geographies where key stakeholders have played an active role in market development. A comparative analysis provides lessons that may be relevant to other rice fortification programs.

Incremental costs of introducing jet injection technology for delivery of routine childhood vaccinations: comparative analysis from Brazil, India, and South Africa.

BACKGROUND: Disposable-syringe jet injectors (DSJIs) have the potential to deliver vaccines safely and affordably to millions of children around the world. We estimated the incremental costs of transitioning from needles and syringes to delivering childhood vaccines with DSJIs in Brazil, India, and South Africa. METHODS: Two scenarios were assessed: (1) DSJI delivery of all vaccines at current dose and depth; (2) a change to intradermal (ID) delivery with DSJIs for hepatitis B and yellow fever vaccines, while the other vaccines are delivered by DSJIs at current dose and depth. The main advantage of ID delivery is that only a small fraction of the standard dose may be needed to obtain an immune response similar to that of subcutaneous or intramuscular injection. Cost categories included were vaccines, injection equipment, waste management, and vaccine transport. Some delivery cost items, such as training and personnel were excluded as were treatment cost savings caused by a reduction in diseases transmitted due to unsafe injections. RESULTS: In the standard dose and depth scenario, the incremental costs of introducing DSJIs per fully vaccinated child amount to US$ 0.57 in Brazil, US$ 0.65 in India and US$ 1.24 in South Africa. In the ID scenario, there are cost savings of US$ 0.11 per child in Brazil, and added costs of US$ 0.45 and US$ 0.76 per child in India and South Africa, respectively. The most important incremental cost item is jet injector disposable syringes. CONCLUSION: The incremental costs should be evaluated against other vaccine delivery technologies that can deliver the same benefits to patients, health care workers, and the community. DSJIs deserve consideration by global and national decision-makers as a means to expand access to ID delivery and to enhance safety at marginal additional cost.

Ultra Rice Technology: Acceptable Micronutrient Losses and Limited Microbial Growth Enable Shelf Life Extension.

Objectives: The objective of this research was to determine if Ultra Rice (UR) fortified grains are shelf stable and suitable for consumption after 24 months (m) of storage and to document micronutrient losses to determine overages that must be included in the initial formulation. A longer shelf life will prevent the unnecessary disposal of fortified grains at 12m, enable fortified rice grains to be blended prior to transport, and increase the likelihood that it will reach vulnerable populations. Methods: UR premix kernels were sampled from a World Vision warehouse in Burundi every 6m over 24 m. The growth of microorganisms was tested in a certified laboratory and compared with the World Food Programme's (WFP) food safety standards for fortified rice: 10,000 /gram for Aerobic colony count, 50 /gram for Bacillus cereus, 0/gram for E. coli, 10 /gram for Coliforms, 100 /gram for Yeasts and moulds, and negative results for Salmonella. Micronutrient losses were calculated between 0 and 24 m, accounting for moisture. Results: Microorganism growth remained at or below the WFP acceptable limits after 24 m of storage. The micronutrient data indicated losses of 0.5% folic acid, 15.0% thiamine, 18.5% iron, and 18.1% zinc after 24 m of storage. Conclusions: The lack of bacterial growth within UR fortified rice suggests it can be safely consumed for at least 24 m following production and the shelf life can be extended to 24 m under similar storage conditions. Micronutrient losses were small and these amounts will be used to calculate overages with greater precision when formulating future micronutrient premix. *Funded by USDA/NIFA.

Treatment of Anemia with Iron-fortified Rice in a School Lunch Program in Burundi.

Objectives: This cluster-randomized trial tested the efficacy of fortified rice for the treatment of anemia in Burundi. Ultra Rice® (UR) premix kernels were manufactured to contain 100% of the recommended nutrient intakes (RNI) for iron, zinc, thiamin, and folic acid for children 7-9 years. The operational feasibility of providing a stable fortified rice product was also assessed in the Burundian context. Methods: Twelve schools were randomly assigned to receive either UR fortified rice or traditional rice for seven months through a school feeding program. Hemoglobin status was evaluated at baseline and follow-up. Data were collected on the organoleptic acceptability of fortified rice, micronutrient stability with the UR technology, and the blend homogeneity of the rice. Results: Anemia was highly prevalent in schools in Muyinga Province. The fortified rice product was considered acceptable to the local community, maintained stable micronutrient levels, and blended homogeneity. Over the course of the study, anemia status and hemoglobin levels improved in both the control and intervention groups. The intervention did not lead to a significantly greater change in hemoglobin level among those children eating fortified rice (β=0.085 g/dl, 95% CI: -0.21-0.38). Conclusions: High prevalence of fever among the children and the high zinc content of the UR formulation are likely responsible for the non-significant improvement in hemoglobin. Anemia interventions in Burundi should implement multiple strategies to eliminate both iron deficiency and infectious causes of anemia. The zinc content of a multiple micronutrient grain should be studied more carefully to maximize iron uptake. *Funded by USDA/NIFA.

An economic evaluation of thermostable vaccines in Cambodia, Ghana and Bangladesh.

This paper evaluates the incremental health and programmatic cost impacts of new vaccine products, as compared to the standard vaccine products in multi-dose vials in Cambodia, Ghana, and Bangladesh. The authors use a cost-effectiveness model to estimate the impacts of introducing four thermostable vaccines with single-dose presentations: measles, yellow fever, bacille Calmette-Guérin, and diphtheria-tetanus-pertussis-hepatitis B. The effectiveness of all of the vaccines increases with the thermostable formats. The incremental costs associated with the introduction of thermostable vaccines increases for three out of four vaccines. Single-dose presentations of thermostable vaccines are potentially cost-effective interventions to reduce childhood deaths and disability in low-resource settings in Asia and Africa.

Freezing temperatures in the vaccine cold chain: a systematic literature review.

The dangers of accidental freezing of vaccines in the cold chain have prompted studies throughout the globe to better characterize the risk. To date, there has been no systematic review of these studies. This analysis highlights that accidental freezing is pervasive and occurs across all segments of the cold chain. Between 14% and 35% of refrigerators or transport shipments were found to have exposed vaccine to freezing temperatures, while in studies that examined all segments of distribution, between 75% and 100% of the vaccine shipments were exposed. More rigorous study designs were associated with higher levels of freeze exposure. As more expensive, freeze-sensitive vaccines are introduced into immunization schedules, freeze prevention will become increasingly critical for ensuring that the world's children are receiving fully potent vaccine.