Molecular Biology Division, National Institute of Nutrition (Indian Council of Medical Research), Hyderabad, Telangana, India.
Micronutrient Research Group, National Institute of Nutrition (Indian Council of Medical Research), Hyderabad, Telangana, India.
Ann N Y Acad Sci. 2019 Feb;1438(1):40-49. doi: 10.1111/nyas.13953. Epub 2018 Aug 21.
Iron deficiency anemia (IDA) is a significant public health issue in India affecting nearly all vulnerable segments of the population. Causes of IDA include low consumption of iron-rich foods combined with poor iron bioavailability of nonheme iron sources. To date, interventions aimed at correcting IDA focus on increasing iron intake through iron supplementation or fortification strategies. In contrast, dietary diversification is a long-term sustainable approach to improve bioavailable iron intake. In this context, the inclusion of vitamin C-rich fruits in the regular diet has proven to improve iron absorption, but the effect on iron status is inconclusive. Considering the ongoing national program for preschoolers in India, we designed a cluster randomized controlled trial (RCT) to test the hypothesis that inclusion of vitamin C-rich fruit in a regular meal would improve iron absorption and lead to better child iron and micronutrient status, cognitive development, gut health, and growth while reducing morbidity. This paper illustrates a context-specific framework and activities to design and functionalize an open-label, three-arm cluster RCT to test a specific hypothesis. The results of this designed trial should generate evidence to inform policy on the effect of a food-based intervention on iron status.
缺铁性贫血（IDA）是印度一个重大的公共卫生问题，影响着几乎所有易受影响的人群。IDA 的原因包括铁摄入量低，加上非血红素铁来源的铁生物利用度差。迄今为止，旨在纠正 IDA 的干预措施主要集中在通过铁补充或强化策略增加铁的摄入。相比之下，饮食多样化是一种长期可持续的方法，可以提高可利用的铁摄入量。在这种情况下，在日常饮食中添加富含维生素 C 的水果已被证明可以提高铁的吸收，但对铁状况的影响尚无定论。考虑到印度正在进行的学龄前儿童国家计划，我们设计了一项整群随机对照试验（RCT），以检验以下假设：在常规膳食中添加富含维生素 C 的水果会改善铁吸收，并导致儿童的铁和微量营养素状况、认知发育、肠道健康和生长状况得到改善，同时降低发病率。本文阐述了一个特定于背景的框架和活动，用于设计和实现一个开放标签、三臂整群 RCT，以检验一个具体的假设。该设计试验的结果应该为基于食物的干预措施对铁状况的影响提供证据，以告知政策。
