Efficacy of a multi micronutrient-fortified drink in improving iron and micronutrient status among schoolchildren with low iron stores in India: a randomised, double-masked placebo-controlled trial.

BACKGROUND/OBJECTIVES: A multiple micronutrient-fortified drink could be an effective strategy to combating micronutrient deficiencies in school going children. To assess the efficacy of a multiple micronutrient-fortified drink in reducing iron deficiency (ID), ID anemia (IDA), anemia and improving micronutrient status among schoolchildren with low iron stores. The study employed a school-based, randomized, double-blind, placebo-controlled design. SUBJECTS/METHODS: Schoolchildren with low serum ferritin (SF <20 µg/l) (n=246), aged 6-12 years were randomly assigned to receive either a multi-micronutrient fortified or an unfortified identical control drink. The drinks were provided 6 days/week for 8 weeks. Anthropometric and biochemical assessments were taken at baseline and endline. RESULTS: Study groups at baseline were comparable, and compliance to the intervention was similar. The overall prevalence of ID, IDA and anemia was 64%, 19% and 24%, respectively. The prevalence of ID, IDA, vitamin C and vitamin B12 deficiencies significantly reduced by 42%, 18%, 21% and 5%, respectively, in the intervention arm (P<0.01) as compared with the control arm at the end of the study. Similarly, the concentration of hemoglobin, SF, vitamin A, vitamin B12, vitamin C and body iron stores were significantly higher in the intervention arm in comparison to the control arm (P<0.001). Red cell folate levels also improved significantly in the intervention arm (P=0.04), however, serum zinc status did not change in either of the study arms. Children who had received the fortified drink had significantly lower odds of being ID (0.15; 95% confidence interval (CI): 0.09-0.27), IDA (0.14; 95% CI: 0.04-0.52), vitamin B12 deficient (0.36; 95% CI: 0.18-0.73) and vitamin C deficient (0.24; 95% CI: 0.13-0.46), after adjusting for baseline age, gender and weight. CONCLUSIONS: The multi micronutrient-fortified drink was efficacious in reducing the prevalence of ID, IDA, vitamin C and vitamin B12 deficiency and improved micronutrient status in schoolchildren.