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      Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12–18 months in India: study protocol for a randomised controlled trial

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          Abstract

          Introduction

          Biofortified crops represent a sustainable agricultural solution for the widespread micronutrient malnutrition in India and other resource-limited settings. This study aims to investigate the effect of the consumption of foods prepared with iron- and zinc-biofortified pearl millet (FeZn-PM) by children on biomarkers of iron and zinc status, growth, and immune function.

          Methods and analysis

          We will conduct a randomised controlled feeding trial in identified slums of Mumbai, India among 200 children aged between 12 and 18 months. Children will be randomised to receive foods prepared with the biofortified PM (FeZn-PM, ICTP8203-Fe) or non-biofortified PM. Anthropometric and morbidity data will be gathered every month for 9 months. Biological samples will be collected at baseline, midline and endline to assess iron and zinc status, including haemoglobin, serum ferritin, serum transferrin receptor, serum zinc, C-reactive protein and alpha-1 acid glycoprotein. Biological samples will be archived for future analyses. The midline measurement will be a random serial sample between baseline and endline. Immune function will be assessed at each time point by the measurement of T cell counts and vaccine responses in a subset, respectively.

          Ethics and dissemination

          This study has obtained clearance from the Health Ministry Screening Committee of the Indian Council of Medical Research. Ethical clearance has been obtained from Cornell University’s Institutional Review Board, the Inter System Biomedica Ethics Committee and St John’s Research Institute’s Institutional Ethics Review Board. The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals.

          Trial registration number

          Clinical trial registration number NCT02233764. CTRI registration number REF/2014/10/007731.

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          Most cited references18

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          Maternal and child undernutrition and overweight in low-income and middle-income countries

          Robert E Black, Cesar G Victora, Susan P. Walker … (2013)
          The Lancet, 382(9890), 427-451
          Article 0 comments Cited 2781 times – based on 0 reviews     Review now
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            Long-term brain and behavioral consequences of early iron deficiency.

            Michael K. Georgieff (2011)
            Early iron deficiency not only affects brain and behavioral function during the period of iron deficiency, it persists long after treatment. The mechanisms include long-term alterations in dopamine metabolism, myelination, and hippocampal structure and function. Recent studies have demonstrated long-term genomic changes, which suggests the regulation of brain function is fundamentally altered.
            Article 0 comments Cited 74 times – based on 0 reviews     Review now
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              Iron supplementation improves appetite and growth in anemic Kenyan primary school children.

              O Lawless, Corinne L. Stephenson, A Pertet … (1994)
              A randomized, double-blind, placebo-controlled iron supplementation trial was conducted in Kenya to examine the effect of iron supplements on appetite and growth in 87 primary school children. Sustained-release ferrous sulfate (150 mg) or placebo tablets were provided daily at school for 14 wk. Prior to tablet administration, baseline anthropometry, iron nutritional status (hemoglobin and serum ferritin), parasitic infections and clinical indicators of morbidity were measured. A baseline appetite test was conducted twice on each child by quantitatively measuring the ad libitum consumption of a midmorning snack. In addition, each child was asked for a subjective assessment of his or her appetite. Follow-up exams and appetite tests were identical to those at baseline. Findings indicated that provision of iron supplements resulted in improved growth and improved appetite (in terms of both energy intake of the snack and child report of appetite) as compared with children receiving the placebo. The increased energy intake from the snack was 10% of the daily estimated energy intake for children of this same age group living elsewhere in Kenya. Further research into the underlying physiological mechanisms may shed light on the relationship between iron nutritional status and appetite.
              Article 0 comments Cited 42 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2017
                Publication date (Electronic): 14 November 2017
                Volume: 7
                Issue: 11
                Electronic Location Identifier: e017631
                Affiliations
                [1 ]departmentDivision of Nutritional Sciences , Cornell University , Ithaca, New York, USA
                [2 ]departmentInstitute for Nutritional Sciences, Global Health, and Technology , Cornell University , Ithaca, New York, USA
                [3 ]departmentDivision of Nutrition , St John’s Research Institute , Bangalore, Maharashtra, India
                [4 ]Kasturba Health Society Medical Research Centre (KHS-MRC) , Mumbai, Maharashtra, India
                [5 ]departmentDepartment of Food Science and Nutrition , Shreemati Nathibai Damodar Thackersey, Women’s University (SNDT) , Mumbai, India
                [6 ]Data Performance LLC , New York, USA
                [7 ]Center for the Study of Social Change , Mumbai, India
                Author notes
                [Correspondence to ] Dr. Saurabh Mehta; smehta@ 123456cornell.edu
                Author information
                http://orcid.org/0000-0003-3788-0665
                Article
                Publisher ID: bmjopen-2017-017631
                DOI: 10.1136/bmjopen-2017-017631
                PMC ID: 5695508
                PubMed ID: 29138201
                SO-VID: b0569575-61b0-4c2b-91da-ed1f4d74023b
                Copyright © © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
                License:

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                Date received : 03 May 2017
                Date revision received : 07 September 2017
                Date accepted : 02 October 2017
                Funding
                Funded by: HarvestPlus;
                Categories
                Subject: Global Health
                Subject: Protocol
                Subject: 1506
                Subject: 1699
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: biofortification,zinc,iron,pearl millet,children,growth
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: biofortification, zinc, iron, pearl millet, children, growth

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