Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
NCT ID: NCT01490944
Last Updated: 2012-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
360 participants
INTERVENTIONAL
2012-01-31
2013-01-31
Brief Summary
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* 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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Iron and Folic Acid
Iron and Folic Acid
Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
Iron, Folic acid and cyanocobalamin
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.
Exclusion Criteria
* Pregnant Adolescent girls
* Medical conditions like TB, Cancer etc
11 Years
18 Years
FEMALE
Yes
Sponsors
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Delhi University
OTHER
Indian Council of Medical Research
OTHER_GOV
Responsible Party
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G.S.Toteja
Scientist-F (Deputy Director General, Senior Grade) and Principal Investigator
Principal Investigators
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Dr. Gurdayal S Toteja, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Indian Council of Medical Research
Priyanka Gupta, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Indian Council of Medical Research
Dr. Neena Bhatia, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Delhi University
Dr. Naval K Vikram, M.D.
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences
Dr. Anupa Siddhu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Delhi University
Locations
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Kirti Nagar Slums
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Gurdayal S Toteja, Ph.D
Role: primary
Priyanka Gupta, M.Sc
Role: backup
References
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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.
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. doi: 10.1016/S0140-6736(96)02341-0.
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.
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. No abstract available.
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.
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. doi: 10.1038/sj.ejcn.1602791. 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. doi: 10.1093/ajcn/60.6.930.
Other Identifiers
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3/1/2/34/10-RHN
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CNRT/Ph.D/4/2010
Identifier Type: -
Identifier Source: org_study_id