To assess the impact of Vitamin B12 supplementation with Iron and Folic Acid on anaemic adolescent girls
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in hemoglobin concentration
研究概览
简要总结
The study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /Delhi. Anaemic adolescent girls (n=360) will be randomly divided into two groups. Group 1(n=180) will be given weekly supplementation of Iron and Folic acid for six months, whereas group 2 (n=180) will be given weekly supplementation of Iron Folic Acid and Vitamin B12 to assess the impact of Vitamin B12 supplementation on reducing the prevalence of anaemia. Anthropometric measurements and dietary information will be collected besides biochemical analysis. IEC sessions will be organized for both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 11.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- Female
入选标准
- •a)Mild or Moderately anaemic girl (11-18 yrs) b)Willingness to participate c)unmarried or married (who still reside with their parents, i.e. prior to ‘Gauna’) adolescent girl.
排除标准
- •a)Adolescent girls with severe anaemia b)Pregnant Adolescent girls c)Adolscent girls suffering from any medical conditions like TB, Cancer etc.
结局指标
主要结局
Change in hemoglobin concentration
时间窗: At the baseline and at the end of the trial, i.e. 6 months
次要结局
- Change in serum ferritin, folic acid and vitamin B12 concentration(baseline and at end of 6 months)