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临床试验/NCT02152150
NCT02152150已完成不适用

Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India

Cornell University1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
246
试验地点
1
主要终点
Change in iron status

研究概览

简要总结

The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet in improving iron status in adolescents in India.

详细描述

An estimated 1.6 billion people worldwide are anemic, and iron deficiency (ID) is the leading cause of anemia. Its prevalence is highest in resource-limited settings, and among children and women of reproductive age. Even mild ID can adversely impact cognitive performance, behavior, and physical growth of children, and physical work and cognitive performance in adults.

Interventions to target micronutrient malnutrition such as dietary diversification, micronutrient supplementation, and food fortification have reduced ID, but have not been universally successful. Biofortification, the process of increasing the concentration and bioavailability of essential nutrients in staple crops by traditional plant breeding, is a sustainable and cost-effective approach to combat micronutrient deficiencies. Other forms of bio-fortification (agronomic management and genetic modification) are also feasible. Rice, maize, wheat, pearl millet, sweet potato, beans, and cassava have been the main target crops of bio-fortification.

Pearl millet (PM) is a primary staple food in India, particularly in the states of Rajasthan, Gujarat and Maharashtra. The high pearl millet consumption and availability of a recently released pearl millet variety (ICTP 8203-Fe) with significantly greater iron content provided an opportunity to evaluate its efficacy on improving iron status in human populations. We hypothesized that daily consumption of iron bio-fortified pearl millet (Fe-PM) would improve iron status in six months. We conducted a randomized efficacy trial of iron bio-fortified pearl millet in improving iron status in adolescents in Maharashtra, India.

The aims of this study are:

  • To determine if the iron status of adolescent boys and girls in rural Maharashtra is improved by consuming high-iron bio-fortified PM
  • To determine if adolescents in rural Maharashtra consuming high-iron bio-fortified PM exhibit higher physical performance and energetic work efficiency compared to adolescent boys and girls consuming low-iron pearl millet.
  • To determine if adolescents in rural Maharashtra consuming high-iron bio-fortified PM exhibit higher cognitive and perceptual functioning, as well as differences in patterns of cortical activation' when compared to children consuming low-iron pearl millet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants are individuals aged 12 to 16 years
  • Attending boarding schools in Ahmednagar district, Maharashtra, India

排除标准

  • Severe anemia (Hemoglobin<8.5g/dL)
  • Taking iron supplements or medications that could interfere with iron absorption
  • Chronic illnesses

结局指标

主要结局

Change in iron status

时间窗: 6 months

Hemoglobin, serum ferritin, serum transferrin receptor, body iron

次要结局

  • Differences in cognitive function(6 months)
  • Differences in physical performance(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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