NCT01418898Unknown4 期
The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Iron status: Change in hemoglobin and serum ferritin
研究概览
简要总结
This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-7 years old
- •Children with parental consent
- •Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
- •No history of blood disorder or malaria
- •Had not participated in any feeding program for the past 4 months
- •Children with Hb > 70 g/L to <120 g/L (WHO/UNICEF/UNU, 1998)
- •CRP <10 mg/L
排除标准
- •All children aged < 5 years old and > 7 years old
- •Without parental consent
- •Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
- •Reported current or history of blood abnormalities/hemoglobinopathies
- •Children with all normal Hb levels or very low Hb < 70 g/L
- •CRP >10mg/L
结局指标
主要结局
Iron status: Change in hemoglobin and serum ferritin
时间窗: Baseline and 4 months
次要结局
- zinc, vitamin A and vitamin C status(Baseline and 4 months)
- Weight, height, CRP and frequency of illness(Baseline and 4 months)
- Dietary intake(Baseline and 4 months)
研究者
研究点 (1)
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