A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12–18 months living in urban slums

BACKGROUND AND AIMS: Biofortification of staple crops with higher concentrations of micronutrients via traditional breeding methods is a sustainable strategy and can possibly complement fortification and other interventions to target micronutrient deficiencies in low resource settings, particularly among populations such as children. We aimed to determine if iron- and zinc-biofortified pearl millet (FeZnPM, Dhanashakti, ICTP-8203Fe)-based complementary feeding improves nutritional status, including iron and zinc biomarkers and growth, in children living in urban slums of Mumbai. METHODS: We conducted a randomized controlled trial of FeZnPM among 223 children aged 12-18 months who were not severely anemic at baseline (hemoglobin ≥9.0 g/dL). Children were randomized to receive either FeZnPM or conventional (non-biofortified) pearl millet (CPM) daily for 9 months. Hemoglobin, serum ferritin, and plasma zinc concentrations as well as growth indicators (length, weight, mid-upper arm circumferences, triceps and subscapular skinfolds) were evaluated at enrollment and throughout the trial. World Health Organization (WHO) anthropometric Z-scores were calculated using WHO growth standards. Primary outcomes were hemoglobin and serum ferritin concentrations, and growth, defined as WHO Z-scores. An intent-to-treat approach was used for analyses. We used the Hodges-Lehmann-Sen test to assess the change in primary outcomes between baseline and the last visit and report corresponding 95 % confidence intervals. RESULTS: At baseline, 49.3 % of children had anemia (hemoglobin