Abstract

ObjectivesTo assess the effectiveness of a nutrition intervention with a multi-micronutrient fortified corn-soy blend (MMC) (ChapuditosTM) vs. standard of care (SOC) in anemia and hemoglobin (Hb) in 6 to 12-mo-old infants from four rural municipalities in La Libertad, El Salvador. MethodsA two-arm, clustered randomized evaluation was implemented between September 2015 and November 2017. A total of n = 384 infants met eligibility criteria: ages 6 to ≤ 12 mo, permanent resident of study locations, no genetic, health conditions or disability, parental consent, having attended 2 consecutive well-child visits. Clinicaltrials.gov registration NCT02567981. A total of n = 195 received SOC: 3 lb of corn-soy blend with dry milk with 18 micronutrients including 1.8 mg of zinc and 3.6 mg of iron per serving, equivalent to 30 daily servings; + 100,000 IU of vitamin A every 6 mo, and 12.5 mg of elemental iron per day via ferrous sulphate. A total of n = 189 received “MMC”: 3 lb of corn-soy blend with 21 micronutrients and high concentrations of chelated zinc (9 mg) and iron (12 mg) per serving, equivalent to 72 daily servings. Capillary blood was drawn at baseline (Bl) and 3 mo. Linear and generalized linear mixed models with binary outcomes were used to assess Bl – 3 mo changes in Hb and anemia, respectively. Models were adjusted by age, sex, Bl outcomes, and cluster. Both nutrition interventions were provided at the scheduled well-child visits. ResultsPreliminary analyses showed that Hb tended to improve from Bl to 3 mo in both groups [Bl-MMC = 10.47g/dL; 95% CI (10.32–10.61), Bl-SOC = 10.26 g/dL; 95% CI (10.12–10.40); 3 mo MMC = 10.88g/dL; 95% CI (10.72–11.04); 3 mo-SOC = 10.43g/dL; 95% CI (10.28–10.60)]. Changes in Hb were significant for the MMC vs. SOC group, [mean difference = 0.41g/dL, P ≤ 0.001; and 0.180g/dL, P = 0.228, respectively]. The odds of anemia were 63% lower in the MMC group, relative to SOC, [OR: 0.37, 95% CI (0.17–0.82)]. ConclusionsA multi-micronutrient cereal with 21 micronutrients and elevated concentrations of chelated zinc and iron may be an effective alternative to current practices in alleviating anemia and improving Hb in this population. Consolidating different multiple-micronutrient delivery methods into one product may simplify provision and adherence, resulting in improved anemia and Hb status. Funding SourcesThis study was funded by the Mathile Institute for the Advancement of Human Nutrition.

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