Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 2
- 主要终点
- Hemoglobin
研究概览
简要总结
The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.
详细描述
In 2007, the National Strategy for Anemia Prevention and Control in Bangladesh included adolescents and newly married women as target groups for future iron and folic acid (IFA) supplementation programs. This double-blinded RCT examined the effect of daily periconceptional IFA vs. folic acid (FA) on anemia and iron indictors before and during pregnancy among married, nulliparous women in rural Bangladesh. Biochemical indices were collected at baseline and either at 15 weeks gestation or after 9 months among non-pregnant women (NPW).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women were eligible if they were:
- •Nulliparous
- •< 40 years old
- •Living in the same household as their husband
排除标准
- •Women were excluded if they were:
- •Pregnant at enrollment
- •Planning to move out of the region
- •Using iron supplements within the previous 3 months
- •Using an implant form of birth control, or had surgery to prevent pregnancy
- •Women with a Hb concentration of < 70 g/L, defined as severely anemic according to WHO definition (5), were excluded from the study and appropriately treated
结局指标
主要结局
Hemoglobin
时间窗: February 2007-February 2008
次要结局
- Plasma ferritin(February 2007-February 2008)
研究者
Stanley Zlotkin
Chief, Global Child Health
The Hospital for Sick Children