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临床试验/NCT00741143
NCT00741143已完成不适用

Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children

St. John's Research Institute2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2007年8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
194
试验地点
2
主要终点
change in cognitive abilities

研究概览

简要总结

This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving cognition, hemoglobin, iron status and total body iron among school children in urban Bangalore.

详细描述

Background: Iron (Fe) deficiency is a major cause of anemia in children. Fortification of wheat flour with NaFeEDTA, a highly bioavailable iron fortificant that protects Fe from the phytic acid present in wheat flour, could be a practical approach to addressing this problem.

Aims: To evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving mental performance and reducing iron deficiency and improving body iron stores in urban, school going Indian children.

Methods: A randomized, double-blind, 7 month, school-based feeding trial was carried out in Bangalore, India. Iron-depleted (serum ferritin, SF <20 µg/L), and/or iron deficient (serum transferrin receptor, TfR >7.6 mg/L), 6 -13 year old children (N=194) were randomly assigned to either receive a whole wheat flour based lunch meal fortified with 6 mg Fe as NaFeEDTA or an identical unfortified control meal. The meals were administered under supervision and left overs were weighed. Hemoglobin (Hb) and iron status were measured at baseline, 3.5 months, and 7 months. At baseline and at 7 months, the study children were also subjected to a battery of cognitive tests to assess attention/concentration, motor development, visuospatial and verbal abilities. Sensory evaluation using triangle tests were carried out using meals prepared from the fortified and unfortified whole wheat flour.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with depleted iron stores (serum ferritin < 20 µg/L or iron deficiency serum transferrin receptor >7.6 mg/L)

排除标准

  • Hb < 8g/dl, any metabolic illness, use of medication, on iron supplementation

结局指标

主要结局

change in cognitive abilities

时间窗: 7 months

次要结局

  • changes in iron status indicators(7 months)

研究者

申办方类型
Other

研究点 (2)

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