Anaemia
Conditions
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.
Interventions
DRUGIron, 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
Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
Sponsors
Delhi University
Indian Council of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Contacts
Primary ContactDr. Gurdayal S Toteja, Ph.D
Backup ContactPriyanka Gupta, M.Sc
Outcome results
None listed