| CTRI Number |
CTRI/2011/12/002217 [Registered on: 08/12/2011] Trial Registered Prospectively |
| Last Modified On: |
16/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to assess impact of iron, folic acid and Vitamin B12 supplementation on anaemic adolescent girls |
|
Scientific Title of Study
|
To assess the impact of Vitamin B12 supplementation with Iron and Folic Acid on anaemic adolescent girls |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G S Toteja |
| Designation |
Scientist F |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research Ramalingaswami Bhawan
Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
011-23731633 |
| Email |
gstoteja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G S Toteja |
| Designation |
Scientist F |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research Ramalingaswami Bhawan
Ansari Nagar New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
011-23731633 |
| Email |
gstoteja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Priyanka Gupta |
| Designation |
Senior Research Fellow |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research Ramalingaswami Bhawan
Ansari Nagar New Delhi
Central
DELHI
110029
India |
| Phone |
|
| Fax |
011-23731633 |
| Email |
priyankaicmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for promotion of nutrition research and training with special focus on northeast tribal and inaccessible population
Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Centre for Promotion of Nutrition Research and Training with special focus on North-East, Tribal & Inaccessible population (Indian Council of Medical Research), ICMR Campus II, Tuberculosis Association of India Building, Ist Floor, 3 Red Cross Road, New Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G S Toteja |
Kirti Nagar |
Kirti Nagar Slums
New Delhi
West
DELHI |
011-23731633
011-23731633
gstoteja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lady Irwin College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mild (Hb: 10-11.9 g%) and moderate anaemia (Hb: 7-9.9 g%) among adolescent girls, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron and Folic Acid |
Iron 100 mg, folic acid 500 mcg and placebo given weekly for 6 months |
| Intervention |
Iron, Folic Acid and Vitamin B12 |
Iron 100 mg given weekly for 6 months, folic acid 500 mcg given weekly for 6 months, Vitamin B12 500 mcg given weekly for 6 weeks followed by 15 mcg for 20 weeks |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
a) Adolescent girls with severe anaemia
b) Pregnant Adolescent girls
c) Adolscent girls suffering from any medical conditions like TB, Cancer etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin concentration |
At the baseline and at the end of the trial, i.e. 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in serum ferritin, folic acid and vitamin B12 concentration |
baseline and at end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 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. |