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 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 Raveendran, Jere D Haas, Julia L Finkelstein, Shobha A Udipi, Project Sabal, 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 Function Testing Administrators, Komal Vilas Devare, Nalini Sakat, Chhaya Vapilkar-Salpe, Cssc Staff, Sunanda 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 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 Rafique Shaikh, Yasmin Shaikh, Nazma Sheikh, Sheetal S Surve, Aditi Tamble, Deepa Tandel, Shraddha Tivrekar, Aswhini Warang, Aswini Warang, Ashwini Pendurkar, Study Physicians, Sirazul Ameen Sahariah, Sanjay Ojha, Feeding Center Managers, Auto-Rickshaw Drivers, Anthony Fernandes, Vittal D Kalogi, 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 Raveendran, Jere D Haas, Julia L Finkelstein, Shobha A Udipi, Project Sabal, 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 Function Testing Administrators, Komal Vilas Devare, Nalini Sakat, Chhaya Vapilkar-Salpe, Cssc Staff, Sunanda 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 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 Rafique Shaikh, Yasmin Shaikh, Nazma Sheikh, Sheetal S Surve, Aditi Tamble, Deepa Tandel, Shraddha Tivrekar, Aswhini Warang, Aswini Warang, Ashwini Pendurkar, Study Physicians, Sirazul Ameen Sahariah, Sanjay Ojha, Feeding Center Managers, Auto-Rickshaw Drivers, Anthony 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).
Keywords: Biofortification; Children; Complementary foods; Growth; Iron; Urban slums.
Conflict of interest statement
Conflict of interest SM has an equity interest in VitaMe Technologies (DBA VitaScan), which is commercializing technology focused on developing point-of-care assays for nutritional status based on his research as a faculty member at Cornell University. The other authors report no conflicts of interest.
Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Source: PubMed