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Clinical trial to assess impact of iron, folic acid and Vitamin B12 supplementation on anaemic adolescent girls

Phase 2
Recruiting
Conditions
Mild (Hb: 10-11.9 g%) and moderate anaemia (Hb: 7-9.9 g%) among adolescent girls
Registration Number
CTRI/2011/12/002217
Lead Sponsor
Indian Council of Medical Research
Brief Summary

The study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /Delhi. Anaemic adolescent girls (n=360) will be randomly divided into two groups. Group 1(n=180) will be given weekly supplementation of Iron and Folic acid for six months, whereas group 2 (n=180) will be given weekly supplementation of Iron Folic Acid and Vitamin B12 to assess the impact of Vitamin B12 supplementation on reducing the prevalence of anaemia. Anthropometric measurements and dietary information will be collected besides biochemical analysis. IEC sessions will be organized for both the groups.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Female
Target Recruitment
360
Inclusion Criteria

a)Mild or Moderately anaemic girl (11-18 yrs) b)Willingness to participate c)unmarried or married (who still reside with their parents, i.e. prior to ‘Gauna’) adolescent girl.

Exclusion Criteria

a)Adolescent girls with severe anaemia b)Pregnant Adolescent girls c)Adolscent girls suffering from any medical conditions like TB, Cancer etc.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in hemoglobin concentrationAt the baseline and at the end of the trial, i.e. 6 months
Secondary Outcome Measures
NameTimeMethod
Change in serum ferritin, folic acid and vitamin B12 concentrationbaseline and at end of 6 months

Trial Locations

Locations (1)

Kirti Nagar

🇮🇳

West, DELHI, India

Kirti Nagar
🇮🇳West, DELHI, India
Dr G S Toteja
Principal investigator
011-23731633
gstoteja@gmail.com

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