Adherence With Iron Sprinkles Among High-Risk Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- full adherence, use of iron supplements 6-7 days/week for 3 months
研究概览
简要总结
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
详细描述
Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.
Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.
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
- None
入排标准
- 年龄范围
- 5 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants
- •Age 5-7 months
- •Presenting for 6 months well-child care
- •Caregiver speaks English or Spanish
排除标准
- •Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
- •Inability to speak English or Spanish
- •Use of vitamin or iron supplements in the previous three months
结局指标
主要结局
full adherence, use of iron supplements 6-7 days/week for 3 months
次要结局
- anemia at 9 months of age
- iron deficiency at 9 months of age