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

• DOI: 10.1016/j.clnu.2022.02.014
• Publication Date: 2022-02-24T07:19:22Z
• Authors: Saurabh Mehta; Samantha L. Huey; Padmini S. Ghugre; Ramesh D. Potdar; Sudha Venkatramanan; Jesse T. Krisher; Caleb J. Ruth; Harsha V. Chopra; Aparna Thorat; Varsha Thakker; Lynn Johnson; Laura Powis; Yadurshini Raveen...; Jere D. Haas; Julia L. Finkelstein; Shobha A. Udipi; Kripa Rajagopalan; Research assistants; Shobaha R. Iyer; Janhavi Sonawane; Tejashree Thorat; Pratiksha Bagal; Pranali Pangerkar; Swati J. Kathar; Priyanka Kadam; Rinki Saw; Chinki Saw; Lalita Saw; Samrutthi Surve; Sona Majethiya; Sonu Mishra; Bansari Rao; Anupriya Pawar; Namrata Shinde; Monthie Fernandes; Ashwini Salvi; Cognitive functi...; Komal Vilas Devare; Nalini Sakat; Chhaya Vapilkar-S...; CSSC staff; Sunanda Chavan; Community health...; Varsha Ambre; Ragini Milind Arde; Bhagyashri C. Bab...; Anuja Sachin Bhale; Sakshi Samir Bhosale; Ankita Arun Devlekar; Yojina Dhanawade; Vaibhavi Dhotre; Afroz Faroqie; Regina Fernandes; Steffie Fernandes; Suvarna Chandan G...; Sangeetha Ghadi; Mayuri Ghag; Shubhada Hardas; Shanta Pundalik H...; Neelam Narayan Ja...; Shivani Jaiswal; Neelam Jalankar; Suneetha Kadam; Janvi Avadhut Kanade; Surekha Anil Karande; Mangal Khade; Bharti Bhimrao Ku...; Jyothi Raghunath ...; Dipika Dipak Main...; Lakshmi Martal; Prachi Pratap Mat...; Satyabhama Nhanu ...; Kiran Ravindra Me...; Tripti Mohite; Akansha A. Naik; Namrata Narkar; Suvarna Santosh P...; Ankita Ashok Pend...; Seetamaya Saw Qam...; Bashirunnisa Shaikh; Tasleem Rafique S...; Yasmin Shaikh; Nazma Sheikh; Sheetal S. Surve; Aditi Tamble; Deepa Tandel; Shraddha Tivrekar; Aswhini Warang; Aswini Warang; Ashwini Pendurkar; Study physicians; Sirazul Ameen Sah...; Sanjay Ojha; Feeding center m...; Auto-rickshaw dr...; Anthony Fernandes; Vittal D. Kalogi
• Keywords: Biofortification

Background & aimsBiofortification of staple crops with higher levels micronutrients via traditional breeding methods is a sustainable strategy and can possibly complement fortification other interventions to target micronutrient deficiencies in low resource settings, particularly among vulnerable populations such as children. We aimed determine if iron- zinc-biofortified pearl millet (FeZnPM, Dhanashakti, ICTP-8203Fe)-based complementary feeding improves nutritional status, including iron biomarkers growth, children living urban slums Mumbai.MethodsWe conducted randomized controlled trial FeZnPM 223 aged 12–18 months who were not severely anemic at baseline (hemoglobin ≥9.0 g/dL). Children receive either or conventional non-biofortified (CPM) daily for 9 months. Iron status (hemoglobin, serum ferritin), plasma zinc, anthropometric indicators (length, weight, mid-upper arm circumference, triceps subscapular skinfolds) evaluated enrollment throughout the trial. World Health Organization (WHO) z-scores calculated using WHO growth standards. Primary outcomes hemoglobin ferritin concentrations, defined z-scores. An intent treat approach was used analyses. Hodges–Lehmann–Sen test assess change primary between last visit report corresponding 95% confidence intervals.ResultsAt baseline, 67.7% <11.0 g/dL) 59.6% deficient (serum <12.0 μg/L). did significantly increase improve compared CPM. In subgroup analyses, improved concentrations male children, deficiency depletion <25.0 μg/L) relative CPM.ConclusionsDaily consumption FeZnPM-based foods impact zinc Mumbai's slums. However, intervention individuals iron-deficient iron-depleted baseline.Trial registrationThis registered Clinicaltrials.gov (ID: NCT02233764), Clinical Trials Registry India REF/2014/10/007731).