Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
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ClinicalTrials.gov Identifier: NCT01490944 |
Recruitment Status
: Unknown
Verified January 2012 by G.S.Toteja, Indian Council of Medical Research.
Recruitment status was: Recruiting
First Posted
: December 13, 2011
Last Update Posted
: February 28, 2012
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anaemia | Drug: Iron, Folic acid and Cyanocobalamin Drug: Iron and Folic Acid | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | November 2012 |
Estimated Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Iron and Folic Acid |
Drug: Iron and Folic Acid
Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
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Experimental: Iron, Folic acid and cyanocobalamin |
Drug: Iron, 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 |
- Change in hemoglobin level [ Time Frame: 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
- Change in serum ferritin, folic acid and vitamin B12 levels [ Time Frame: 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

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Ages Eligible for Study: | 11 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490944
Contact: Dr. Gurdayal S Toteja, Ph.D | +91-11-23731633 | gstoteja@gmail.com | |
Contact: Priyanka Gupta, M.Sc | +91-11-26890602 | priyankaicmr@gmail.com |
India | |
Kirti Nagar Slums | Recruiting |
New Delhi, Delhi, India, 110015 | |
Contact: Gurdayal S Toteja, Ph.D +91-11-23731633 gstoteja@gmail.com | |
Contact: Priyanka Gupta, M.Sc +91-11-26890602 priyankaicmr@gmail.com | |
Principal Investigator: Gurdayal S Toteja, Ph.D | |
Principal Investigator: Priyanka Gupta, M.Sc |
Principal Investigator: | Dr. Gurdayal S Toteja, Ph.D | Indian Council of Medical Research | |
Principal Investigator: | Priyanka Gupta, M.Sc | Indian Council of Medical Research | |
Principal Investigator: | Dr. Neena Bhatia, Ph.D | Delhi University | |
Principal Investigator: | Dr. Naval K Vikram, M.D. | All India Institute of Medical Sciences, New Delhi | |
Principal Investigator: | Dr. Anupa Siddhu, Ph.D | Delhi University |
Publications:
Responsible Party: | G.S.Toteja, Scientist-F (Deputy Director General, Senior Grade) and Principal Investigator, Indian Council of Medical Research |
ClinicalTrials.gov Identifier: | NCT01490944 History of Changes |
Other Study ID Numbers: |
CNRT/Ph.D/4/2010 3/1/2/34/10-RHN ( Other Grant/Funding Number: Indian Council of Medical Research ) |
First Posted: | December 13, 2011 Key Record Dates |
Last Update Posted: | February 28, 2012 |
Last Verified: | January 2012 |
Additional relevant MeSH terms:
Iron Folic Acid Vitamin B 12 Hydroxocobalamin Vitamin B Complex Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Hematinics Vitamins |