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

February 25, 2012 updated by: G.S.Toteja, Indian Council of Medical Research

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Gurdayal S Toteja, Ph.D
  • Phone Number: +91-11-23731633
  • Email: gstoteja@gmail.com

Study Contact Backup

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110015
        • Recruiting
        • Kirti Nagar Slums
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gurdayal S Toteja, Ph.D
        • Principal Investigator:
          • Priyanka Gupta, M.Sc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and at end of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indian Council of Medical Research

Collaborators

Delhi University

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, 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

January 1, 2013

Study Registration Dates

First Submitted

December 11, 2011

First Submitted That Met QC Criteria

December 11, 2011

First Posted (ESTIMATE)

December 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNRT/Ph.D/4/2010
  • 3/1/2/34/10-RHN (OTHER_GRANT: Indian Council of Medical Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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