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

NCT01490944 | Unknown Phase 2 DMC

• 2 other identifiers: CNRT/Ph.D/4/20103/1/2/34/10-RHN
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

• 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

Conditions

Anaemia

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin level

  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 Outcomes (1)

• Change in serum ferritin, folic acid and vitamin B12 levels

  at baseline and at end of 6 months

Study Arms (2)

Iron and Folic Acid

ACTIVE COMPARATOR

Drug: Iron and Folic Acid

Iron, Folic acid and cyanocobalamin

EXPERIMENTAL

Drug: Iron, Folic acid and Cyanocobalamin

Interventions

Iron, Folic acid and Cyanocobalamin DRUG

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

Iron, Folic acid and cyanocobalamin

Iron and Folic Acid DRUG

Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months

Iron and Folic Acid

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willingness to participate
• Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.

You may not qualify if:

• Severe anaemia
• Pregnant Adolescent girls
• Medical conditions like TB, Cancer etc

Sponsors & Collaborators

• Indian Council of Medical Research: lead
• Delhi University: collaborator

Study Sites (1)

Kirti Nagar Slums

New Delhi, National Capital Territory of Delhi, 110015, India

RECRUITING

Related Publications (15)

• Basu RN, Sood SK, Ramachandran K, Mathur M, Ramalingaswami V. Etiopathogenesis of nutritional anemia in pregnancy: a therapeutic approach. Am J Clin Nutr. 1973 Jun;26(6):591-4. doi: 10.1093/ajcn/26.6.591. No abstract available.

  PMID: 4575153 BACKGROUND

• Sood SK, Ramachandran K, Mathur M, Gupta K, Ramalingaswamy V, Swarnabai C, Ponniah J, Mathan VI, Baker SJ. W.H.O. sponsored collaborative studies on nutritional anaemia in India. 1. The effects of supplemental oral iron administration to pregnant women. Q J Med. 1975 Apr;44(174):241-58.

  PMID: 1103213 BACKGROUND

• Gomber S, Agarwal KN, Mahajan C, Agarwal N. Impact of daily versus weekly hematinic supplementation on anemia in pregnant women. Indian Pediatr. 2002 Apr;39(4):339-46.

  PMID: 11976463 BACKGROUND

• Kotecha PV, Nirupam S, Karkar PD. Adolescent girls' Anaemia Control Programme, Gujarat, India. Indian J Med Res. 2009 Nov;130(5):584-9.

  PMID: 20090111 BACKGROUND

• Agarwal KN, Gomber S, Bisht H, Som M. Anemia prophylaxis in adolescent school girls by weekly or daily iron-folate supplementation. Indian Pediatr. 2003 Apr;40(4):296-301.

  PMID: 12736400 BACKGROUND

• Bruner AB, Joffe A, Duggan AK, Casella JF, Brandt J. Randomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet. 1996 Oct 12;348(9033):992-6. doi: 10.1016/S0140-6736(96)02341-0.

  PMID: 8855856 BACKGROUND

• Ahmed F, Khan MR, Akhtaruzzaman M, Karim R, Marks GC, Banu CP, Nahar B, Williams G. Efficacy of twice-weekly multiple micronutrient supplementation for improving the hemoglobin and micronutrient status of anemic adolescent schoolgirls in Bangladesh. Am J Clin Nutr. 2005 Oct;82(4):829-35. doi: 10.1093/ajcn/82.4.829.

  PMID: 16210713 BACKGROUND

• Deshmukh PR, Garg BS, Bharambe MS. Effectiveness of weekly supplementation of iron to control anaemia among adolescent girls of Nashik, Maharashtra, India. J Health Popul Nutr. 2008 Mar;26(1):74-8.

  PMID: 18637530 BACKGROUND

• Sen A, Kanani SJ. Impact of iron-folic acid supplementation on cognitive abilities of school girls in Vadodara. Indian Pediatr. 2009 Feb;46(2):137-43.

  PMID: 19242031 BACKGROUND

• Shobha S, Sharada D. Efficacy of twice weekly iron supplementation in anemic adolescent girls. Indian Pediatr. 2003 Dec;40(12):1186-90.

  PMID: 14722370 BACKGROUND

• Singla PN, Bhardwaj B, Agarwal DK, Agarwal KN. Vitamin B12 and folic acid in preschool anemia. Indian Pediatr. 1985 Jan;22(1):27-33. No abstract available.

  PMID: 4077257 BACKGROUND

• Singla PN, Gupta HP, Ahuja C, Agarwal KN. Deficiency anaemias in preschool children--estimation of prevalence based on response to haematinic supplementation. J Trop Pediatr. 1982 Apr;28(2):77-80. doi: 10.1093/tropej/28.2.77. No abstract available.

  PMID: 6763946 BACKGROUND

• Mozaffari-Khosravi H, Noori-Shadkam M, Fatehi F, Naghiaee Y. Once weekly low-dose iron supplementation effectively improved iron status in adolescent girls. Biol Trace Elem Res. 2010 Jun;135(1-3):22-30. doi: 10.1007/s12011-009-8480-0. Epub 2009 Aug 4.

  PMID: 19652922 BACKGROUND

• Hettiarachchi M, Liyanage C, Wickremasinghe R, Hilmers DC, Abrams SA. The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka. Eur J Clin Nutr. 2008 Jul;62(7):856-65. doi: 10.1038/sj.ejcn.1602791. Epub 2007 May 16.

  PMID: 17522609 BACKGROUND

• Worthington-White DA, Behnke M, Gross S. Premature infants require additional folate and vitamin B-12 to reduce the severity of the anemia of prematurity. Am J Clin Nutr. 1994 Dec;60(6):930-5. doi: 10.1093/ajcn/60.6.930.

  PMID: 7985636 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Iron; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Dr. Anupa Siddhu, Ph.D

  Delhi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gurdayal S Toteja, Ph.D

CONTACT

+91-11-23731633; gstoteja@gmail.com

Priyanka Gupta, M.Sc

CONTACT

+91-11-26890602; priyankaicmr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist-F (Deputy Director General, Senior Grade) and Principal Investigator

Study Record Dates

• First Submitted: December 11, 2011
• First Posted: December 13, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 28, 2012

Record last verified: 2012-01

Locations

IN (1)