Improve Micronutrient Intake Research Articles

Driving Policy Change to Improve Micronutrient Status in Women of Reproductive Age and Children in Southeast Asia: The SMILING Project.

Objective The SMILING (Sustainable Micronutrient Interventions to Control Deficiencies and Improve Nutritional Status and General Health in Asia) project aimed at creating awareness and improving policies around micronutrient deficiencies in five Southeast Asian countries (Vietnam, Laos, Thailand, Cambodia and Indonesia). Results The project showed large gaps in recent data on micronutrient status in most of the five countries. By updating existing, or creating national food composition tables, the SMILING project enabled analyses of food consumption in women of reproductive age and young children. Linear programming showed a high risk for multiple micronutrient deficiencies in these groups, and especially in pregnant women. Most programs to improve micronutrient status target iodine, iron and vitamin A deficiency. However, the high prevalence of zinc, vitamin D, thiamine and folate deficiency in the region warrant interventions too. For certain micronutrients (zinc, iron, calcium), dietary changes alone appeared not enough to fulfill requirements. Food fortification was identified to be a sustainable, long-term solution to improve micronutrient intake. Multiple criteria mapping by stakeholders in each country resulted in a list of country-specific priority interventions. Surprisingly, food fortification was ranked low, due to concerns on quality control and organoleptic changes of the fortified food. More advocacy is needed for new, innovative interventions such as delayed cord clamping. Conclusions for practice The SMILING project recommends regular surveys to monitor micronutrient status of population, to measure impact of interventions and to guide nutrition policies.

Biofortified crops for tackling micronutrient deficiencies – what impact are these having in developing countries and could they be of relevance within Europe?

AbstractThe development of crops that by harvest have accumulated higher amounts of a particular micronutrient than standard crops is known as biofortification. Biofortified staple crops such as provitamin A‐biofortified sweet potato (‘orange sweet potato’), zinc‐biofortified rice (‘zinc rice’) and iron‐biofortified beans (‘iron beans’), developed by selective breeding, have been introduced into developing countries with the goal of reducing micronutrient deficiencies. In these settings, micronutrient deficiencies caused by low dietary intakes and exacerbated by inflammation and infection result in considerable morbidity and mortality worldwide. The aim of this review is twofold: (1) to describe the impact of biofortified crops on micronutrient intake, nutritional status and other biological endpoints in developing countries and (2) to consider the relevance of these nutritional effects in other parts of the world such as Europe. Regular consumption of biofortified crops in developing countries where micronutrient deficiency is common has been shown to increase micronutrient intakes and thus help meet the World Health Organization's dietary recommendations. In terms of micronutrient status, most research has been conducted using provitamin A‐biofortified crops (particularly orange sweet potato), with large 2‐ to 3‐year studies indicating increases in plasma retinol, though additional studies measuring change in body stores would provide more definitive evidence. There is some evidence to suggest that iron‐biofortified crops can increase iron status (measured by serum ferritin and total body iron), but further studies are required to demonstrate the efficacy of zinc‐biofortified foods. Intakes of some micronutrients are low in someUKpopulation subgroups (in particular adolescents and young adult women), with sizeable proportions having intakes below the lower reference nutrient intake. There is also evidence of low status for some nutrients (e.g. iron and in particular vitamin D), although the prevalence of iron deficiency is much less, and therefore the consequences less severe, than seen in the developing world. The final part of the paper describes strategies used to improve micronutrient intake in Europe, such as fortification of bread flour post‐harvest and supplementation with vitamin D and folic acid, and discusses whether there is a role for biofortified crops in theUK.

Head and Neck Cancer Patients Do Not Meet Recommended Intakes of Micronutrients without Consuming Fortified Products

ABSTRACTThis study assessed dietary and micronutrient intakes of head and neck cancer (HNC) patients at key points in the disease trajectory and evaluated the contribution of oral nutritional supplements (ONS) to micronutrient intake. HNC patients (n = 114) completed a three-day dietary record and a tool to assess Nutrition Impact Scores (NIS) at baseline, post-treatment, and follow-up. Foods were classified into food categories. Micronutrient, protein, and energy intakes were compared to European Society for Parenteral and Enteral Nutrition guidelines for cancer patients. The majority of patients did not meet recommended dietary intakes for vitamins D, E, C, folate, and magnesium at any study time point. Relative to baseline, the proportion of calories from milk, soup, and ONS significantly increased at post-treatment, while grain, meat, potato, baked dessert, and oil and sugar decreased (P < 0.03). At all study time points, patients categorized as high ONS consumers (>15% of total daily calories from ONS) had higher intakes of micronutrients (P < 0.003). They also had a higher NIS (P = 0.006) and experienced greater weight loss (P < 0.04) during the study, despite having similar energy intake to patients consuming <15% kcal from ONS. Fortification of usually consumed foods to improve micronutrient intake among cancer patients should be evaluated.

The potential role of micronutrient powders to improve complementary feeding practices

Micronutrient powder (MNP) interventions are often integrated within infant and young child feeding (IYCF) programmes to improve micronutrient intake from complementary foods. This review aims to describe country experiences with MNP interventions and their impact on IYCF practices and develop a framework for how MNP may strengthen complementary feeding practices. A literature review and key informant interviews were used to gather data on complementary feeding practices in MNP programme design, implementation, and evaluation. Findings from 11 MNP programmes in different geographic regions reinforced the potential of MNP interventions to add renewed focus and resources to existing IYCF programmes. MNP plays an important role in ensuring adequate micronutrient intake and reducing anaemia in young children. In some programmes, MNP users had improved IYCF practices, such as breastfeeding to 24months and children receiving complementary foods with adequate consistency, frequency, and diversity. Our framework highlights how behaviour change communication is an essential component for influencing household actions, not only to generate demand and promote correct and sustained MNP use but also raise awareness of IYCF practices. The actions at MNP policy, delivery, and behaviour change communication levels collectively influence household IYCF practices, and formative research and monitoring and evaluation serve to inform programme design and optimize impact. In conclusion, a limited but growing body of evidence suggests that MNP interventions can contribute to improve complementary feeding practices. However, there is scope for improvement even among integrated MNP and IYCF programmes in order to realize the full potential of MNP interventions for IYCF practices.

SUN-LB328: Low Volume Energy Dense Oral Nutritional Supplements Improve Micronutrient Intakes in free Living Malnourished Older People – A Randomised Trial

SUN-LB328: Low Volume Energy Dense Oral Nutritional Supplements Improve Micronutrient Intakes in free Living Malnourished Older People – A Randomised Trial

Are Low Intakes and Deficiencies in Iron, Vitamin A, Zinc, and Iodine of Public Health Concern in Ethiopian, Kenyan, Nigerian, and South African Children and Adolescents?

To perform a systematic review to evaluate iron, vitamin A, zinc, and iodine status and intakes in children and adolescents (0-19 years) in Ethiopia, Kenya, Nigeria, and South Africa. Both national and subnational data published from the year 2005 to 2015 were searched via MEDLINE, Scopus, and national public health websites. For each micronutrient and country, status data from relevant studies and surveys were combined into an average prevalence and weighted by sample size (WAVG). Inadequate intakes were estimated from mean (SD) intakes. This review included 55 surveys and studies, 17 from Ethiopia, 11 from Kenya, 12 from Nigeria, and 16 from South Africa. The WAVG prevalence of anemia ranged from 25% to 53%, iron deficiency from 12% to 29%, vitamin A deficiency (VAD) from 14% to 42%, zinc deficiency from 32% to 63%, and iodine deficiency from 15% to 86% in children aged 0 to 19 years from 4 countries. Generally, children <5 years had higher prevalence of anemia (32%-63%), VAD (15%-35%), and zinc deficiency (35%-63%) compared to children aged 5 to 19 years. Studies with intake data indicated that inadequate intakes ranged from 51% to 99% for zinc, 13% to 100% for iron, and 1% to 100% for vitamin A. Households failing to consume adequately iodized (>15 ppm) salt ranged from 2% in Kenya to 96% in Ethiopia. With large variation within the 4 African countries, our data indicate that anemia and vitamin A, zinc, and iodine deficiencies are problems of public health significance. Effective public health strategies such as dietary diversification and food fortification are needed to improve micronutrient intake in both younger and older children.

Instant noodles made with fortified wheat flour to improve micronutrient intake in Asia: a review of simulation, nutrient retention and sensory studies.

Consumption of foods made with wheat flour, particularly instant noodles, is increasing in Asia. Given this trend, fortifying wheat flour with vitamins and minerals may improve micronutrient intake in the region. The objective of this review was to understand what is known about fortifying wheat flour used to make instant noodles. A literature review of seven databases was performed using the search terms "noodle" and ("Asian" or "instant"). Grey literature was requested through a food fortification listserv. Articles were title screened first for relevance and duplicity, with exclusion criteria applied during the second round of abstract-level screening. This review considered studies examining simulation, retention, sensory, bioavailability, efficacy, and effectiveness of instant noodles made with fortified wheat flour. Fourteen relevant documents were reviewed for simulation (n=1), retention (n=11), and sensory studies (n=3). The documents revealed that instant noodles produced from fortified wheat flour have potential to improve nutrient intakes, have high retention of most nutrients, and provoke no or minimal changes in sensory characteristics. The available literature indicates that using fortified wheat flour for instant noodle production results in retention of the added nutrients, except thiamin, with no significant sensory change to the final product. Given the rising consumption of instant noodles, production of this item with fortified wheat flour has potential to improve nutrient intakes in Asia. This review provides a resource for the design of a wheat flour fortification program in countries where a large proportion of wheat flour is consumed as instant noodles.

Fortified breakfast cereal consumed daily for 12 wk leads to a significant improvement in micronutrient intake and micronutrient status in adolescent girls: a randomised controlled trial.

BackgroundPoor micronutrient status is reported among adolescents across Europe and USA. This may be related to the well-documented decline in the regular consumption of breakfast by this group. The regular consumption of a breakfast cereal offers a possible means to improve micronutrient status; fortified cereal is likely to have enhanced benefit. A study was conducted to determine the efficacy of the regular consumption of a fortified cereal with milk, compared with unfortified cereal, consumed either as a breakfast or a supper, in improving micronutrient intake and micronutrient status of adolescent girls.MethodsA randomised, double-blind, placebo-controlled intervention trial was conducted in girls recruited at ages 16–19 years, from schools and colleges in Sheffield, UK. Girls were randomised to receive 50 g fortified or unfortified cereal, with 150 ml semi-skimmed milk, daily, for 12 weeks, as a breakfast or as a supper. Dietary intake was estimated using a 4-d food diary and blood collected for the assessment of nutritional status. Within-group changes were tested using a paired sample t test; two-way ANOVA was used to analyse effects of the intervention, with cereal type and time of consumption as factors, correcting for baseline values. The analysis was conducted on 71 girls who completed the study.ResultsConsumption of unfortified cereal elicited an increase in the intake of vitamins B1, B2 and B6; consumption of fortified cereal elicited increases in vitamins B1, B2, B6, B12, folate and iron (P < 0.001) and of vitamin D (P = 0.007), all increases were significantly greater than for unfortified cereal. Consumption of the fortified cereal also led to a significant improvement in biomarkers of status for vitamins B2, B12, folate and of iron, compared with girls receiving the unfortified cereal, and maintained vitamin D status, in contrast with the girls receiving the unfortified cereal (P < 0.001).ConclusionsThe daily consumption of cereal with milk for 12 weeks by adolescent girls, increased intakes of micronutrients. The consumption of fortified cereal elicited greater increases than for unfortified cereal and improved biomarkers of micronutrient status. The findings justify strategies to encourage the consumption of fortified cereal with milk by adolescents, either as a breakfast or a supper.Trial registrationRegistered with Current Controlled Trials (Registration: ISRCTN55141306)

Micronutrient Intake among Children in Puerto Rico: Dietary and Multivitamin-Multimineral Supplement Sources.

Micronutrients are critical for healthy growth and development of children. Micronutrient intake from dietary sources is inadequate among some children and may be improved by use of multivitamin and multimineral (MVMM) supplements. To assess micronutrient intake from dietary and MVMM supplement sources among 12-year-old children in Puerto Rico. A representative sample of 732 children enrolled in an oral health study in Puerto Rico, who completed dietary and MVMM assessments through one 24-h recall, were included in this analysis. Micronutrient intake sources were described and compared to the Dietary Reference Intakes (DRIs) using the Estimated Average Requirement when available (used Adequate Intake for vitamin K and pantothenic acid). Micronutrient profiles of MVMM users and non-users were compared using t-tests. Mean intakes of vitamins A, D, E, and K, pantothenic acid, calcium, and magnesium from food and beverage sources were below the DRIs. From food and beverage sources, MVMM users had higher intakes of riboflavin and folate compared to non-users (p < 0.05). When MVMM supplements were taken into account, users had higher intakes of all nutrients except vitamin K. With the help of MVMM, users increased intake of vitamins E, A, D, and pantothenic acid to IOM-recommended levels but calcium, magnesium, and vitamin K remained below guidelines. Micronutrient intake from diet was below the IOM-recommended levels in the total sample. MVMM use improved intake of selected micronutrients and facilitated meeting recommendations for some nutrients. Public health measures to improve micronutrient intake among children in Puerto Rico are needed.

Micronutrient Intake in Children in Puerto Rico and the Contribution of Dietary Supplement Use

Multivitamin and multimineral (MVMM) supplement use in children is associated with adequate intake of micronutrients. This has not been properly studied in Hispanic children.ObjectiveTo assess micronutrient intake and contribution of MVMM supplements in 12‐year‐old children in Puerto Rico (PR). Methods: As part of an “island‐wide” study in 1,550 children, diet and supplement use were assessed with a 24hr recall in a representative subsample (n=796). Micronutrient intake was compared among MVMM users and non‐users from food and beverages sources and supplements using t‐test.ResultsIn this analysis, only children using MVMM (9.3%) or not using any supplements and with complete data were included (n=732). Overall, the following nutrients were below the Dietary Reference Intakes (DRI) from food and beverages: vitamins A, D, E, and K, pantothenic acid, calcium and magnesium. Users had higher intakes of folate and riboflavin from the diet. When nutrients from supplements were added, users had higher intakes of all nutrients except vitamin K. Among non‐users, boys had higher intakes of calcium, copper, iron, magnesium, zinc, and most B vitamins than girls. Essential nutrients for bone mass accretion (calcium, magnesium and vitamins D and K) were below the DRIs. When supplements were taken into account, intakes of these nutrients, except vitamin D, were still below the DRIs.ConclusionUse of MVMM supplements helped reach the DRIs but important nutrients are still below recommendations. Public health measures to improve micronutrient intake among children in PR are needed.

Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age (Review)

Vitamin and mineral deficiencies, particularly those of iron, vitamin A and zinc, affect more than two billion people worldwide. Young children are highly vulnerable because of rapid growth and inadequate dietary practices. Micronutrient powders (MNP) are single-dose packets containing multiple vitamins and minerals in powder form that can be sprinkled onto any semi-solid food.The use of MNP for home or point-of-use fortification of complementary foods has been proposed as an intervention for improving micronutrient intake in children under two years of age. To assess the effects and safety of home (point-of-use) fortification of foods with multiple micronutrient powders on nutritional, health and developmental outcomes in children under two years of age. We searched the following databases in February 2011: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE (1948 to week 2 February 2011), EMBASE (1980 to Week 6 2011), CINAHL (1937 to current), CPCI-S (1990 to 19 February 2011), Science Citation Index (1970 to 19 February 2011), African Index Medicus (searched 23 February 2011), POPLINE (searched 21 February 2011), ClinicalTrials.gov (searched 23 February 2011), mRCT (searched 23 February 2011), and World Health Organization International Clinical Trials Registry Platform (ICTRP) (searched 23 February 2011). We also contacted relevant organisations (25 January 2011) for the identification of ongoing and unpublished studies. We included randomised and quasi-randomised trials with either individual or cluster randomisation. Participants were children under the age of two years at the time of intervention, with no specific health problems. The intervention was consumption of food fortified at the point of use with multiple micronutrient powders formulated with at least iron, zinc and vitamin A compared with placebo, no intervention or the use of iron containing supplements, which is the standard practice. Two review authors independently assessed the eligibility of studies against the inclusion criteria, extracted data from included studies and assessed the risk of bias of the included studies. We included eight trials (3748 participants) conducted in low income countries in Asia, Africa and the Caribbean, where anaemia is a public health problem. The interventions lasted between two and 12 months and the powder formulations contained between five and 15 nutrients. Six trials compared the use of MNP versus no intervention or a placebo and the other two compared the use of MNP versus daily iron drops. Most of the included trials were assessed as at low risk of bias. Home fortification with MNP reduced anaemia by 31% (six trials, RR 0.69; 95% CI 0.60 to 0.78) and iron deficiency by 51% (four trials, RR 0.49; 95% CI 0.35 to 0.67) in infants and young children when compared with no intervention or placebo, but we did not find an effect on growth. In comparison with daily iron supplementation, the use of MNP produced similar results on anaemia (one trial, RR 0.89; 95% CI 0.58 to 1.39) and haemoglobin concentrations (two trials, MD -2.36 g/L; 95% CI -10.30 to 5.58); however, given the limited amount of data these results should be interpreted cautiously. No deaths were reported in the trials and information on side effects and morbidity, including malaria, was scarce. It seems that the use of MNP is efficacious among infants and young children six to 23 months of age living in settings with different prevalences of anaemia and malaria endemicity, regardless of whether the intervention lasts two, six or 12 months or whether recipients are male or female. Home fortification of foods with multiple micronutrient powders is an effective intervention to reduce anaemia and iron deficiency in children six months to 23 months of age. The provision of MNP is better than no intervention or placebo and possibly comparable to commonly used daily iron supplementation. The benefits of this intervention as a child survival strategy or on developmental outcomes are unclear. Data on effects on malaria outcomes are lacking and further investigation of morbidity outcomes is needed. The micronutrient powders containing multiple nutrients are well accepted but adherence is variable and in some cases comparable to that achieved in infants and young children receiving standard iron supplements as drops or syrups.

Rice Fortification: Its Potential for Improving Micronutrient Intake and Steps Required for Implementation at Scale

Micronutrient deficiencies affect over 2 billion people worldwide, with profound implications for health, cognitive development, education, economic development, and productivity. Fortification of staple foods is a cost-effective strategy to increase vitamin and mineral intake among the general population. Rice is consumed by billions of people (> 440 million MT/year) but is as yet rarely fortified. To discuss the untapped opportunity of rice fortification. Review literature and experience with rice fortification and compare to fortification of other staple foods. Most technologies used to fortify rice first produce the fortified kernels and then blend them with regular, polished rice. Technologies differ with regard to how nutrients are added to the rice kernels, required investment, production cost, and degree of resemblance to unfortified rice. There are, so far, limited success stories for rice fortification. Some of the main roadblocks appear to be high initial investment and associated cost; lack of government leadership; and consumer hesitation to accept variations in the characteristics of rice, or a higher price, without good understanding of the benefits. In countries with a large centralized rice milling industry, starting rice fortification is easier than in countries with many small mills. Countries with large safety nets that supply rice to the poorest, for free or subsidized, have a good channel to reach those most in need. Furthermore, key players from the public and private sectors should establish a coalition to support the use of fortified rice and address some of the barriers to its implementation.

Food Groups Associated with a Composite Measure of Probability of Adequate Intake of 11 Micronutrients in the Diets of Women in Urban Mali1–4

The prevalence of micronutrient deficiency is high among women of reproductive age living in urban Mali. Despite this, there are little data on the dietary intake of micronutrients among women of reproductive age in Mali. This research tested the relationship between the quantity of intake of 21 possible food groups and estimated usual micronutrient (folate, vitamin B-12, calcium, riboflavin, niacin, vitamin A, iron, thiamin, vitamin B-6, vitamin C, and zinc) intakes and a composite measure of adequacy of 11 micronutrients [mean probability of adequacy (MPA)] based on the individual probability of adequacy (PA) for the 11 micronutrients. Food group and micronutrient intakes were calculated from 24-h recall data in an urban sample of Malian women. PA was lowest for folate, vitamin B-12, calcium, and riboflavin. The overall MPA for the composite measure of 11 micronutrients was 0.47 ± 0.18. Grams of intake from the nuts/seeds, milk/yogurt, vitamin A-rich dark green leafy vegetables (DGLV), and vitamin C-rich vegetables food groups were correlated (Spearman’s rho = 0.20–0.36; P < 0.05) with MPA. Women in the highest consumption groups of nuts/seeds and DGLV had 5- and 6-fold greater odds of an MPA > 0.5, respectively. These findings can be used to further the development of indicators of dietary diversity and to improve micronutrient intakes of women of reproductive age.

Processes involved in developing palatable micronutrient-rich snacks for a pre-conceptional and intra-pregnancy intervention trial: The Mumbai Maternal Nutrition Project

The objective of the current study was to develop palatable food supplements produced from locally-available vegetarian ingredients that would improve the quality of the diet of young Indian women living in Mumbai slums. The supplements were to be used as a daily intervention in a currently-ongoing randomised controlled trial testing the hypothesis that ‘enhancing the micronutrient content of women’s diets before and during pregnancy would improve fetal growth and development of their offspring’. A vehicle in the form of a cooked snack food, prepared by kitchen staff recruited from the local slum community in a low-tech kitchen, was developed. The snack was distributed to women 6 d/week and was designed to provide supplementary green leafy vegetables (GLV), fruit and milk Samples of the snacks were chemically analysed to measure target levels of nine ‘marker’ nutrients. Acceptability of the snack was assessed by holding sensory evaluation sessions with project staff and trial participants assigning scores to the snacks based on taste, texture and appearance. As an objective measure of acceptability the women’s compliance with consuming the intervention was recorded on a daily basis by project health workers throughout the trial and these data were used to assess the uptake of each snack as the trial progressed. Results of sensory evaluation, objective compliance assessment and nutrient analyses were used to develop a vehicle that met the requirements for improving micronutrient intake, while at the same time being palatable and acceptable to the women. Over the course of the trial a variety of recipes were distributed to the women to prevent monotony. Acceptability and some target micronutrient levels were achieved using combinations of fresh GLV, dried fruits and milk powder. All snacks contained ‡ 25 g one or more of a variety of fresh locally-sourced GLV e.g. coriander (Coriandrum sativum), colocasia (Colocasia esculenta) or radish leaf (Raphanus sativus), 12 g milk powder and ‡ 4 g dehydratedfruit. In addition, the snacks contained binding ingredients such as chickpea (Cicer arietinum) flour or jowar (sorghum) flour. Mean micronutrient levels of the final product (per 60 g serving) were: b-carotene 123 retinol equivalents; folate 68 mg; riboflavin 0.14 mg; Fe 4.9 mg; Ca 195 mg; vitamin B12 0.24 mg. These values are between 12 % and 43 % of the UK estimated average requirements (2) . Target vitamin C levels were not achieved. It has been demonstrated that it is possible to develop palatable culturally-acceptable and safe micronutrient-rich food supplements using a ‘low-tech’ approach, a local work-force and locally-available fresh and dehydrated ingredients. The effect of these supplements on the nutritional status of the mothers and the health outcomes of their babies is yet to be reported.

Micronutrient interventions and HIV infection: a review of current evidence

To review the current evidence on the role of micronutrient supplementation in HIV transmission and progression. Literature review. The importance of micronutrients in the prevention and treatment of childhood infections is well known, and evidence is emerging that micronutrient interventions may also affect HIV transmission and progression. Interventions to improve micronutrient intake and status could contribute to a reduction in the magnitude and impact of the global HIV epidemic. However, more research is needed before specific recommendations can be made.

Can supplements help meet the micronutrient needs of the developing world?

Supplementation has many potential advantages over fortification and dietary approaches for improving micronutrient intake. Pregnant and lactating women and infants are most likely to benefit from supplementation. Recent experience with vitamin A supplementation in young children has proved to be remarkably successful. Demonstrated efficacy of vitamin A supplements for improved child survival in many settings and a technical consensus on how to implement interventions were major factors in achieving this success. Bilateral and UN agencies worked together so that in 1999 80 % of children under 5 years of age in the least-developed countries received a vitamin A capsule in the last 6 months. At least one million child lives saved were associated with the increase in coverage in the last 2 years of the 1990s. Experience with Fe-folate supplements has not been as successful. Whilst a technical consensus has been reached on how to implement programmes to control Fe deficiency, the lack of convincing evidence of efficacy of Fe-folate supplements in terms of maternal and child survival outcomes has undoubtedly contributed to the limited pursuit of effective action. A new multiple micronutrient supplement for use amongst women of reproductive age in developing countries has been formulated. UNICEF is employing the supplement in programmes aimed at helping to prevent low birth weight. The new supplement is likely to be more efficacious than Fe-folate supplements for both maternal and child survival and development outcomes. Successful completion of rigorous efficacy trials will be critical for creating the political support needed to achieve universal coverage.