A Phase 2 interventional study of Iron, Folic acid and Cyanocobalamin and Iron and Folic Acid in Anaemia, sponsored by Indian Council of Medical Research. Status unknown at 1 site in India. Open to female participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-28.
Sponsored by Indian Council of Medical Research · Phase 2, Interventional, and Treatment
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.
Duration of supplementation: 6 months
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 360 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
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Drug: Iron and Folic Acid
Drug: Iron, Folic acid and Cyanocobalamin
Drug pages: Iron · Folic Acid · Vitamin B 12
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
Drug pages: Iron · Folic Acid
Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
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
Time frame: at baseline and after 6 months
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
Time frame: at baseline and at end of 6 months
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Iron · Folic Acid · Vitamin B 12
Indian Council of Medical Research