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

Anaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01490944
• Other study ID #: CNRT/Ph.D/4/2010
• Secondary ID: 3/1/2/34/10-RHN
• Status: Recruiting
• Phase: Phase 2
• First received: December 11, 2011
• Last updated: February 25, 2012
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2012
• Source: Indian Council of Medical Research
• Contact: Dr. Gurdayal S Toteja, Ph.D
• Phone: +91-11-23731633
• Email: gstoteja[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 18 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anaemia

Intervention

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

Locations

Country	Name	City	State
India	Kirti Nagar Slums	New Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Indian Council of Medical Research	Delhi University

Country where clinical trial is conducted

India, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in serum ferritin, folic acid and vitamin B12 levels	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	No