Clinical trial NCT01490944: Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
Official title: Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anaemia
Lead sponsor: Indian Council of Medical Research
Sponsor class: OTHER_GOV
Collaborators: name: Delhi University
First posted: 2011-12-13
Enrollment: 360
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hemoglobin level
timeFrame: at baseline and after 6 months
Secondary outcomes:
measure: Change in serum ferritin, folic acid and vitamin B12 levels
timeFrame: at baseline and at end of 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Kirti Nagar Slums
state: Delhi
Study officials:
affiliation: Indian Council of Medical Research
name: Dr. Gurdayal S Toteja, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Indian Council of Medical Research
name: Priyanka Gupta, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Delhi University
name: Dr. Neena Bhatia, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Dr. Naval K Vikram, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Delhi University
name: Dr. Anupa Siddhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
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