Estimation of oxidative stress in pregnant women on daily versus weekly iron supplementation (An ICMR Task Force Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- oxidative stress status in plasma of pregnant women taking oral iron in daily versus weekly doses for anemia prevention
研究概览
简要总结
This randomized controlled clinical trial at a tertiary level hospital, recruited primi para women in 2 phases in their first trimester and supplemented oral iron in two schedules. One is 100 mg elemental iron daily and another is 200 mg elemental iron weekly. Detailed dietary history, oxidative stress parameters and micro-nutrients were tested to estimate the oxidative stress in normal pregnant women while supplementing iron in daily and weekly doses. After completion of 650 enrollments, data is under analysis for effect on total and subgroups, both ways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 20-30 years Hemoglobin is above 11 gm/dl Middle socio-economic income group.
排除标准
- •History of chronic ailment Taking any iron preparation already at the time of enrollment.
结局指标
主要结局
oxidative stress status in plasma of pregnant women taking oral iron in daily versus weekly doses for anemia prevention
时间窗: At three point of time tests were conducted. Oxidative stress, micro nutrient and diet were assessed at the time of enrollment 14-16 weeks of primi pregnancy, after 3 months of supplementation and third time at 6 weeks post delivery
次要结局
- effect of pregnancy on oxidative stress, relationship of oxidative stress with birth outcome and effect of daily versus weekly iron on side effects, acceptability and mode of delivery(At 3 point of time, blood samples and information were sought from study participants, at baseline (14-16 weeks pregnancy, thirst trimester, 6 weeks post delivery)