RETRACTED: A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums
Saurabh Mehta, Samantha L Huey, Padmini Ghugre, Ramesh D. Potdar, Sudha Venkatramanan, Jesse T. Krisher, Caleb Ruth, Harsha Chopra, Aparna Thorat, Varsha Thakker, Lynn M. Johnson, Laura Powis, Yadurshini Raveendran, Jere D. Haas, Julia L. Finkelstein, Shobha Udipi, Kripa Rajagopalan, Shobaha R. Iyer, Janhavi Sonawane, Tejashree Thorat, Pratiksha Bagal, Pranali Pangerkar, Swati J. Kathar, Priyanka Kadam, Rinki Saw, C. B. Saw, Lalita Saw, Samrutthi Surve, Sona Majethiya, Sonu Mishra, Bansari Rao, Anupriya Pawar, Namrata Shinde, Monthie Fernandes, Ashwini Salvi, Cognitive function testing administrators, Komal Vilas Devare, Nalini Sakat, Chhaya Vapilkar-Salpe, CSSC staff, S. J. Chavan, Community health workers and project clerks, Varsha Ambre, Ragini Milind Arde, Bhagyashri C. Babrekar, Anuja Sachin Bhale, Sakshi Samir Bhosale, Ankita Arun Devlekar, Yojina Dhanawade, Vaibhavi Dhotre, Afroz Faroqie, Regina França Fernandes, Steffie Fernandes, Suvarna Chandan Ganekar, Sangeetha Ghadi, Mayuri Ghag, Shubhada Hardas, Shanta Pundalik Hiddujikar, Neelam Narayan Jadhav, Shivani Jaiswal, Neelam Jalankar, Suneetha Kadam, Janvi Avadhut Kanade, Surekha Anil Karande, Mangal Khade, Bharti Bhimrao Kumbhar, Jyothi Raghunath Lokhande, Dipika Dipak Maingade, Lakshmi Martal, Prachi Pratap Mathkar, Satyabhama Nhanu Matondkar, Kiran Ravindra Mestry, Tripti Mohite, Akansha A. Naik, Namrata Narkar, Suvarna Santosh Parab, Ankita Ashok Pendurkar, Seetamaya Saw Qamrunisa Shah, Bashirunnisa Shaikh, Tasleem Shaikh, Yasmin Shaikh, Nazma Sheikh, Sheetal S. Surve, Aditi Tamble, Deepa Tandel, Shraddha Tivrekar, Aswhini Warang, Aswini Warang, Ashwini Pendurkar, Study physicians, Sirazul A. Sahariah, Sanjay Kumar Ojha, Feeding center managers, Auto-rickshaw drivers, A.E. Ribeiro Fernandes, Vittal D. Kalogi
Abstract
BACKGROUND & AIMS: Biofortification of staple crops with higher levels 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 vulnerable 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 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. Iron status (hemoglobin, serum ferritin), plasma zinc, and anthropometric indicators (length, weight, mid-upper arm circumference, 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, 67.7% of children were anemic (hemoglobin <11.0 g/dL) and 59.6% were iron deficient (serum ferritin <12.0 μg/L). FeZnPM did not significantly increase iron biomarkers or improve growth, compared to CPM. In subgroup analyses, FeZnPM improved hemoglobin concentrations in male children, and in children with iron deficiency or iron depletion (serum ferritin <25.0 μg/L) at baseline, relative to CPM. CONCLUSIONS: Daily consumption of FeZnPM-based complementary foods did not significantly impact iron and zinc status or growth in children living in Mumbai's urban slums. However, the intervention significantly improved hemoglobin concentrations among male children and among individuals who were iron-deficient or iron-depleted at baseline. TRIAL REGISTRATION: This trial is registered with Clinicaltrials.gov (ID: NCT02233764), and Clinical Trials Registry of India (ID: REF/2014/10/007731).