Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
This study is currently recruiting participants.
Verified January 2012 by Indian Council of Medical Research
Sponsor:
Indian Council of Medical Research
Collaborator:
Lady Irwin College, University of Delhi
Information provided by (Responsible Party):
G.S.Toteja, Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT01490944
First received: December 11, 2011
Last updated: February 25, 2012
Last verified: January 2012
| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | December 11, 2011 | ||||||||||||||||||||
| Last Updated Date | February 25, 2012 | ||||||||||||||||||||
| Start Date ICMJE | January 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Change in hemoglobin level [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01490944 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Change in serum ferritin, folic acid and vitamin B12 levels [ Time Frame: at baseline and at end of 6 months ] [ Designated as safety issue: No ] 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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls | ||||||||||||||||||||
| Official Title ICMJE | Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls | ||||||||||||||||||||
| 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.
Duration of supplementation: 6 months |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Phase 2 | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Anaemia | ||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 360 | ||||||||||||||||||||
| Estimated Completion Date | January 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||||||
| Ages | 11 Years to 18 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01490944 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | CNRT/Ph.D/4/2010, 3/1/2/34/10-RHN | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | G.S.Toteja, Indian Council of Medical Research | ||||||||||||||||||||
| Study Sponsor ICMJE | Indian Council of Medical Research | ||||||||||||||||||||
| Collaborators ICMJE | Lady Irwin College, University of Delhi | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Indian Council of Medical Research | ||||||||||||||||||||
| Verification Date | January 2012 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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