Clinical nutrition (Edinburgh, Scotland) · 2026
A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12-18 months living in urban slums.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Mehta Saurabh, Huey Samantha L, Ghugre Padmini S, Potdar Ramesh D, Venkatramanan Sudha, Krisher Jesse T, Ruth Caleb J, Chopra Harsha V, Thorat Aparna, Thakker Varsha, Johnson Lynn, Powis Laura, Raveendran Yadurshini, Rajagopalan Kripa, Haas Jere D, Finkelstein Julia L, Udipi Shobha A, Project Sabal
Аннотация
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 <10.5 g/dL) and 59.6 % had iron deficiency (serum ferritin <12 μg/L). Consumption of FeZnPM increased hemoglobin concentration compared to CPM [change over time: 0.10 g/dL (-0.60, 0.90) vs. CPM: -0.15 g/dL (-1.00, 0.40) P = 0.04]. After follow-up, FeZnPM did not increase the concentration of serum ferritin or plasma zincor improve growth, compared to CPM (P > 0.05). Though the trial was not designed to detect this difference, the prevalence of anemia at endpoint was 33.8 % among those consuming FeZnPM, compared to 57.6 % in the CPM group (P = 0.005).
CONCLUSIONS: Daily consumption of FeZnPM-based complementary foods improved hemoglobin concentrations and reduced prevalence of anemia in children living in Mumbai's urban slums. However, the intervention did not significantly impact serum ferritin, plasma zincor growth outcomes.
TRIAL REGISTRATION: This trial is registered with Clinicaltrials.gov (ID: NCT02233764), and Clinical Trials Registry of India (ID: REF/2014/10/007731).
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 <10.5 g/dL) and 59.6 % had iron deficiency (serum ferritin <12 μg/L). Consumption of FeZnPM increased hemoglobin concentration compared to CPM [change over time: 0.10 g/dL (-0.60, 0.90) vs. CPM: -0.15 g/dL (-1.00, 0.40) P = 0.04]. After follow-up, FeZnPM did not increase the concentration of serum ferritin or plasma zincor improve growth, compared to CPM (P > 0.05). Though the trial was not designed to detect this difference, the prevalence of anemia at endpoint was 33.8 % among those consuming FeZnPM, compared to 57.6 % in the CPM group (P = 0.005).
CONCLUSIONS: Daily consumption of FeZnPM-based complementary foods improved hemoglobin concentrations and reduced prevalence of anemia in children living in Mumbai's urban slums. However, the intervention did not significantly impact serum ferritin, plasma zincor growth outcomes.
TRIAL REGISTRATION: This trial is registered with Clinicaltrials.gov (ID: NCT02233764), and Clinical Trials Registry of India (ID: REF/2014/10/007731).