Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls - Full Text View

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:

MedlinePlus related topics: B Vitamins Folic Acid Iron

Drug Information available for: Folic acid Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin

U.S. FDA Resources

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 (Child, Adult)
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

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

More Information

Publications:

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.

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.

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.

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

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.

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.

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.

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.

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.

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

Singla PN, Bhardwaj B, Agarwal DK, Agarwal KN. Vitamin B12 and folic acid in preschool anemia. Indian Pediatr. 1985 Jan;22(1):27-33.

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.

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.

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. Epub 2007 May 16.

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.


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:


Vitamins Folic Acid Vitamin B 12 Hydroxocobalamin Vitamin B Complex Iron	Micronutrients Growth Substances Physiological Effects of Drugs Hematinics Trace Elements

ClinicalTrials.gov processed this record on September 30, 2016