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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anaemia

Intervention / Treatment
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* Drug: Iron, Folic acid and Cyanocobalamin
* Drug: Iron and Folic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron and Folic Acid<br> | Drug: Iron and Folic Acid<br>* Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months<br>|
| Experimental: Iron, Folic acid and cyanocobalamin<br> | Drug: Iron, Folic acid and Cyanocobalamin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin level | 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 | at baseline and after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum ferritin, folic acid and vitamin B12 levels | 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 | at baseline and at end of 6 months |