Anaemia Clinical Trial
Official title:
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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