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

Indian Council of Medical Research (ICMR)

Status and phase: Unknown; Phase 2

Conditions: Anaemia

Treatments: Drug: Iron and Folic Acid; Drug: Iron, Folic acid and Cyanocobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT01490944

CNRT/Ph.D/4/2010

3/1/2/34/10-RHN (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

Iron and Folic Acid

Active Comparator group

Treatment:

Drug: Iron and Folic Acid

Iron, Folic acid and cyanocobalamin

Experimental group

Treatment:

Drug: Iron, Folic acid and Cyanocobalamin