| CTRI Number |
CTRI/2015/01/005380 [Registered on: 09/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Community Based Approach for Combating Anaemia Among Adolescent Girls in Rural Areas of Coimbatore District |
|
Scientific Title of Study
|
Community based approach for
combating anaemia among adolescent girls in rural areas of
Coimbatore district" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUJATHA K |
| Designation |
Research Assistant |
| Affiliation |
Avinashilingam Institute for Home science and Higher Education for women, |
| Address |
Research Assistant
Department of Food Science and Nutrition
Avinashilingam Institute for Home science and Higher Education for women, Coimbatore-641043 for Women,Coimbatore – 641 043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9942169246 |
| Fax |
|
| Email |
saisujatha28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KOWSALYA S |
| Designation |
Professor |
| Affiliation |
Avinashilingam Institute for Home science and Higher Education for women, |
| Address |
Department of Food Science and Nutrition
Avinashilingam Institute for Home science and Higher Education for women, Coimbatore-641043 for Women,Coimbatore – 641 043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994017702 |
| Fax |
|
| Email |
kowsiskk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUJATHA K |
| Designation |
Research Assistant |
| Affiliation |
Avinashilingam Institute for Home science and Higher Education for women, |
| Address |
Research Assistant
Department of Food Science and Nutrition
Avinashilingam Institute for Home science and Higher Education for women, Coimbatore-641043 for Women,Coimbatore – 641 043
TAMIL NADU
641043
India |
| Phone |
9942169246 |
| Fax |
|
| Email |
saisujatha28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, New Delhi |
|
|
Primary Sponsor
|
| Name |
DST SEED New Delhi |
| Address |
Department of Science and Technology
Technology Bhavan
New Mehrauli Road
New Delhi 110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Avinashilingam University |
Avinashilingam University
Coimbatore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sujatha K |
Five villages of thondamuthur block , Coimbatore |
Coimbatore
Coimbatore
TAMIL NADU |
9942169246
saisujatha28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC, Avinashilingam University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anaemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I |
Nutrition Education - 2hour/ month - period of 6 months |
| Intervention |
Group II |
GLV supplement - 50g for a period of 6 months
Nutrition Education - 2 hour/month - period of 6 months |
| Intervention |
Group III |
Nutrition Education - 2 hours / month for a period of 6 months
GLV supplementation obtained from Kitchen garden - 50 gm for a period of 6 months
|
| Comparator Agent |
Group IV |
Nutrition Education - 2hours for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
Women willing to participate and sign written consent
|
|
| ExclusionCriteria |
| Details |
Subjects aged below 13 and above 18 years
not willing to participate
Refuse to sign written consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in hemoglobin and iron status
Increased awareness on GLV consumption
Awareness on symptoms and prevention of Anemia |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in anthropometric measurements
Changes in KAP |
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Present study is a randomized , open label,
parallel group,, intervention trial for
3 months comprising of method demonstration, kitchen garden activity,
Nutrition Education for anaemic adolescent girls and rural women of
thondamuthur villages of Coimbatore district
of , Tamil Nadu |