食用铁和锌生物强化珍珠粟对印度12 - 18个月儿童生长和免疫能力的影响：一项随机对照试验的研究方案
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.
作者信息
Mehta Saurabh, Finkelstein Julia L, Venkatramanan Sudha, Huey Samantha L, Udipi Shobha A, Ghugre Padmini, Ruth Caleb, Canfield Richard L, Kurpad Anura V, Potdar Ramesh D, Haas Jere D
机构信息
Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.
Institute for Nutritional Sciences, Global Health, and Technology, Cornell University, Ithaca, New York, USA.
出版信息
BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631.
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.
引言
生物强化作物是解决印度及其他资源有限地区普遍存在的微量营养素营养不良问题的可持续农业解决方案。本研究旨在调查儿童食用用铁和锌生物强化珍珠粟（FeZn-PM）制作的食物对铁和锌状态、生长及免疫功能生物标志物的影响。
方法与分析
我们将在印度孟买选定的贫民窟对200名12至18个月大的儿童进行一项随机对照喂养试验。儿童将被随机分组，分别食用用生物强化珍珠粟（FeZn-PM，ICTP8203-Fe）或非生物强化珍珠粟制作的食物。连续9个月每月收集人体测量和发病率数据。在基线、中期和末期收集生物样本，以评估铁和锌状态，包括血红蛋白、血清铁蛋白、血清转铁蛋白受体、血清锌、C反应蛋白和α-1酸性糖蛋白。生物样本将存档以备将来分析。中期测量将是基线和末期之间的随机系列样本。分别通过测量T细胞计数和一部分儿童的疫苗反应在每个时间点评估免疫功能。
伦理与传播
本研究已获得印度医学研究理事会卫生部筛查委员会的批准。已获得康奈尔大学机构审查委员会、跨系统生物医学伦理委员会和圣约翰研究所机构伦理审查委员会的伦理批准。本研究结果将在多个研究会议上公布，并作为同行评审期刊上发表的文章传播。
试验注册号
临床试验注册号NCT02233764。CTRI注册号REF/2014/10/007731。
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