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临床试验/CTRI/2017/07/009131
CTRI/2017/07/009131已完成不适用

Efficacy trial for a low cost Iron with Vitamin C drink for reducing Anemia

Jamsetji Tata Trust1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2016年9月29日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Hb

研究概览

简要总结

Iron deficiency (ID) and iron deficiency anemia (IDA) are globally considered as the most prevalent nutrient deficiency in the world. The sheer number of lives affected worldwide is shocking, It is estimated that 2 billion people worldwide are iron deficient including one billion who suffer from IDA(1). In India, 74% of the children below 5 years of age and 52% of young women have anemia (2). Poor dietary iron intake (3) and decreased iron absorption are the two main factors responsible for nutritional iron deficiency affecting poor populations (4). Plant based diets commonly consumed in

India and other developing countries have low iron content and also contain an abundance of phytates and polyphenols that inhibit the absorption of dietary non-heme iron (5), by forming insoluble complexes, thereby making it unavailable for absorption (6, 7). Rice is predominantly consumed and iron content of rice-based diets could be in the range of about 7mg/1000 Kcal. Data from an unpublished survey of primary school children in Karnataka, where the median iron intake was found to be about 10 mg/day. Assuming a generous bioavailability of 5% across all intakes, the median iron absorbed would be about 0.5 mg/day. Thus for a child with 1mg iron as the physiological requirement per day he/she will have a daily deficit of0.5 mg/day, or half the

child’s requirement is only met. Over the days and years this deficit accrues and is further worsened by the increase in iron requirement around puberty.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
7.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • 1.Aged 7-11 years 2.Low socioeconomic status 3.Serum Ferritin <30 µg/L.

排除标准

  • 1.Severe anemia (Hb<8g/dL) 2.Female with onset of menarche 3.Elevated serum CRP (>10 mg/L) 4.Need for any chronic prescription or over-the-counter medication 5.Intention to leave the school during the course of this study.

结局指标

主要结局

Hb

时间窗: Baseline and End line

serum transferrin receptor

时间窗: Baseline and End line

Serum Ferritin

时间窗: Baseline and End line

C - reactive protein

时间窗: Baseline and End line

次要结局

  • height and weight(Baseline and End line)

研究者

申办方类型
Other [trust]

研究点 (1)

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