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

Phase 2

• Conditions: Anaemia
• Interventions: Drug: Iron and Folic Acid; Drug: Iron, Folic acid and Cyanocobalamin

• Registration Number: NCT01490944
• Lead Sponsor: Indian Council of Medical Research

Brief 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.

Study Timeline

• Study First Submitted: 2011-12-11
• Study First Submitted QC: 2011-12-11
• Study First Posted: 2011-12-13
• Status Verified: 2012-01
• Study Start: 2012-01
• Last Update Submitted: 2012-02-25
• Last Update Posted: 2012-02-28
• Primary Completion: 2012-11
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• Willingness to participate
• Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.

Exclusion Criteria

• Severe anaemia
• Pregnant Adolescent girls
• Medical conditions like TB, Cancer etc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron and Folic Acid	Iron and Folic Acid	-
Iron, Folic acid and cyanocobalamin	Iron, Folic acid and Cyanocobalamin	-

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin level	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

Secondary Outcome Measures

Name	Time	Method
Change in serum ferritin, folic acid and vitamin B12 levels	at baseline and at end of 6 months	The secondary outcome would be to assess the change in level of serum ferritin, folic acid and Vitamin B12 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

Trial Locations

Locations (1)

Kirti Nagar Slums; 🇮🇳 New Delhi, Delhi, India