Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Anemia
研究概览
简要总结
This study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. Half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.
详细描述
Iron deficiency is the most prevalent nutritional deficiency and the main cause of anemia. It's estimated that 43% of pre-school children worldwide are anemic, in Argentina a national survey carried out in 2007 (last survey), showed that 34.5% of children less than 2 years old were anemic and that 50.8% of children 6 to 9 months old were anemic. Although there is a consensus on iron supplementation as a preventive strategy for anemia in infants, there is a poor adherence due mainly to mild gastrointestinal adverse effects and low prescription rates from pediatricians. On the other hand, the excess of iron can lead to genomic instability with structural and functional alterations on proteins, lipids and DNA. Weekly administration of iron has been proposed as an alternative of similar efficacy and higher effectiveness in older children and pregnant women, but sufficient evidence for infants is lacking.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessor: the outcomes are defined by hemoglobin and ferritin (corrected by CRP), also genomic instability is defined by a laboratory result such as comet assay. The members of the laboratory will receive labeled specimens with a code unrelated to the allocated arm.
The investigators that will analyze the data will not carry out the study. All the clinical data will be obtained by the care providers.
入排标准
- 年龄范围
- 3 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3 months old infants, clinically healthy, born to term (>37 weeks), that weighted at birth between 2500 and 4000 g, that have normal prenatal records.
排除标准
- •anemic or iron deficient infants, or that have a chronic pathology, or that have undergone an acute pathology in the previous 15 days. Children that are receiving antibiotics or vitamin supplements.
研究组 & 干预措施
Weekly Iron
Weekly ferrous sulfate: one dose (4mg/kg/week).
干预措施: Weekly Ferrous Sulfate (Drug)
Daily Iron
Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg
干预措施: Daily Ferrous Sulfate (Drug)
结局指标
主要结局
Anemia
时间窗: 7 days
Hemoglobin \<11.0 g/dL in 6 months old infants.
次要结局
- Genomic Instability(15 days)
- Adherence(Through study completion, an average of 1 year)
- Iron deficiency(7 days)
- Adverse effects(Through study completion, an average of 1 year)