NCT01490944

Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Indian Council of Medical Research · Other Government
• Sex: Female
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	Iron, Folic acid and Cyanocobalamin	Total duration= 6 months Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 500 mcg weekly supplementation in the form of capsule for 6 weeks Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 15 mcg weekly supplementation in the form of capsule for next 20 weeks
DRUG	Iron and Folic Acid	Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2011-12-13
• Last updated: 2012-02-28

Locations

1 site across 1 country: India