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
  Purpose

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 Intervention Phase
Anaemia
Drug: Iron, Folic acid and Cyanocobalamin
Drug: Iron and Folic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls

Resource links provided by NLM:


Further study details as provided by Indian Council of Medical Research:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 360
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490944

Contacts
Contact: Dr. Gurdayal S Toteja, Ph.D +91-11-23731633 gstoteja@gmail.com
Contact: Priyanka Gupta, M.Sc +91-11-26890602 priyankaicmr@gmail.com

Locations
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         
Sponsors and Collaborators
Indian Council of Medical Research
Lady Irwin College, University of Delhi
Investigators
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
  More Information

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
Study First Received: December 11, 2011
Last Updated: February 25, 2012
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Iron
Vitamins
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on August 21, 2014