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Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Indian Council of Medical Research.
Recruitment status was  Recruiting
Sponsor:
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

December 11, 2011
February 25, 2012
January 2012
November 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01490944 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anaemia
  • 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

  • Drug: Iron and Folic Acid
    Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
  • Active Comparator: Iron and Folic Acid
    Intervention: Drug: Iron and Folic Acid
  • Experimental: Iron, Folic acid and cyanocobalamin
    Intervention: Drug: Iron, Folic acid and Cyanocobalamin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Female
11 Years to 18 Years
Yes
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
 
NCT01490944
CNRT/Ph.D/4/2010, 3/1/2/34/10-RHN
Yes
G.S.Toteja, Indian Council of Medical Research
Indian Council of Medical Research
Lady Irwin College, University of Delhi
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 Lady Irwin College, University of Delhi
Principal Investigator: Dr. Naval K Vikram, M.D. All India Institute of Medical Sciences, New Delhi
Principal Investigator: Dr. Anupa Siddhu, Ph.D Lady Irwin College, University of Delhi
Indian Council of Medical Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP