NCT00374790已完成2 期
Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean zinc protoporphyrin concentration
研究概览
简要总结
The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and placebo given for 6 months in preventing the elevation of blood lead concentration in children 6-9 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants included if gestational age >36 weeks, birth weight > 2500g, no chronic illness, blood lead concentration <10 mcg/dL, hemoglobin >9 g/dL, zinc protoporphyrin >90 mmol/mol heme
- •Mothers included if 18 years or older
- •Exclusion criteria:
- •Hemoglobin >11.5 g/dL
排除标准
- 未提供
结局指标
主要结局
Mean zinc protoporphyrin concentration
Incidence of blood lead concentrations > 10 mcg/dL
Mean hemoglobin concentration
次要结局
- Anthropometry
- Oxidative stress
研究者
研究点 (1)
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