Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
试验速览
- 阶段
- 2 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in hemoglobin level
研究概览
简要总结
The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be randomly divided into two groups.
- Group 1: IFA weekly supplementation along with Information, Education, Communication sessions
- Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education, Communication sessions
Duration of supplementation: 6 months
详细描述
The study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in Delhi. Anaemic adolescent girls (n=360) will be randomly divided into two groups. Group 1(n=180) will be given weekly supplementation of Iron (100 mg) and Folic acid (500 mcg) for six months, whereas group 2 (n=180) will be given weekly supplementation of Iron Folic Acid and cyanocobalamin (Vitamin B12) to assess the impact of Vitamin B12 supplementation on reducing the prevalence of anaemia. For first six weeks, 500 mcg/ week of cyanocobalamin will be given , followed by maintenance dose of 15 mcg/ week for rest of 20 weeks.
Anthropometric measurements and dietary information will be collected besides biochemical analysis. IEC sessions will be organized for both the groups.The study hypothesis is that Vitamin B12 supplementation along with iron folic acid (IFA) is more effective in reducing the prevalence of anaemia as compared to IFA supplementation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate
- •Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.
排除标准
- •Severe anaemia
- •Pregnant Adolescent girls
- •Medical conditions like TB, Cancer etc
研究组 & 干预措施
Iron and Folic Acid
干预措施: Iron and Folic Acid (Drug)
Iron, Folic acid and cyanocobalamin
干预措施: Iron, Folic acid and Cyanocobalamin (Drug)
结局指标
主要结局
Change in hemoglobin level
时间窗: at baseline and after 6 months
The primary outcome would be to assess the change in hemoglobin level after intervention with Iron Folic acid \& cyanocobalamin weekly supplementation for 6 months and to compare the results with the group 1 in which only Iron and Folic acid would be supplemented
次要结局
- Change in serum ferritin, folic acid and vitamin B12 levels(at baseline and at end of 6 months)
研究者
G.S.Toteja
Scientist-F (Deputy Director General, Senior Grade) and Principal Investigator
Indian Council of Medical Research