| CTRI Number |
CTRI/2025/03/082636 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Assessment Of Weekly Iron Folic Acid Supplementation with and without Health Education on Anaemic Adolescent Girls of Government Schools of Haldwani |
|
Scientific Title of Study
|
Assessment Of Weekly Iron Folic Acid Supplementation with and without Health Education on Anaemic Adolescent Girls of Government Schools of Haldwani: A Cluster Randomized Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajnandini Dutt |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Community Medicine, Government Medical College, Haldwani, Nainital, Uttarakhand.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9756892626 |
| Fax |
|
| Email |
rajnandini.dutt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sadhana Awasthi |
| Designation |
Professor & HOD |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Community Medicine, Government Medical College, Haldwani.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9756892626 |
| Fax |
|
| Email |
drsadhna1810@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajnandini Dutt |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of Community Medicine, Government Medical College, Haldwani, Nainital
Nainital
UTTARANCHAL
263139
India |
| Phone |
9756892626 |
| Fax |
|
| Email |
rajnandini.dutt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajnandini Dutt |
| Address |
Department of Community Medicine, Government Medical College, Haldwani, Nainital, Uttarakhand, India, 263139 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rajnandini Dutt |
Government Girls Inter College, Haldwani |
Class 11 & 12, Government Girls Inter College,Motahaldu, Haldwani
Nainital
UTTARANCHAL |
9756892626
rajnandini.dutt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT MEDICAL COLLEGE, HALDWANI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ANAEMIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
In one group of anemic adolescent girls health education will be provided along with Iron folic acid supplementation |
| Comparator Agent |
Only Iron folic acid supplementation, No Health Education |
In this group of anemic adolescent girls only iron folic acid supplementation will be given without health health education. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls of senior secondary (11th & 12th class) with mild (Hb:11-11.9md/dl) to moderate anaemia (Hb: 8-10.9) (who are attending school and willing to participate after taking consent from their parents) |
|
| ExclusionCriteria |
| Details |
Adolescent girls of senior secondary who has severe anemia, girls who are chronically ill and not willing to participate. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Weekly Iron and Folic Acid Supplementation with and without Health education in anaemic adolescent girls. |
Baseline, 3rd month & 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of anaemia in adolescent school going girls in Haldwani block of Nainital district
To study & compare the Knowledge, Attitude & Practice of students of both groups |
Baseline & 6 month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study, titled "Assessment of Weekly Iron Folic Acid Supplementation with and without Health Education on Anaemic Adolescent Girls of Government Schools of Haldwani: A Cluster Randomized Trial," aims to evaluate the effectiveness of combining weekly iron-folic acid (IFA) supplementation with health education in addressing anemia among adolescent girls in government schools. This 18-month cluster randomized trial will involve 200 participants (100 in each arm) with mild to moderate anemia (Hb levels 8-11.9 g/dL). It will estimate anemia prevalence, compare the impact of IFA supplementation alone versus its combination with health education, and analyze Knowledge, Attitude, and Practices (KAP) related to anemia. Using multistage random sampling, the study will measure hemoglobin levels, collect sociodemographic data, and assess KAP through structured questionnaires. Health education will focus on anemia prevention, dietary practices, and iron absorption. The findings aim to reduce anemia prevalence, improve health outcomes, and enhance awareness, providing insights for integrating health education into public health programs like the WIFS. This research addresses a critical health issue and promotes sustainable behavior change among adolescent girls. |