| CTRI Number |
CTRI/2025/11/098142 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional Interventions] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to check the impact of Nutritional Interventions for Prevention of Iron Deficiency Anemia among Adolescent Girls |
|
Scientific Title of Study
|
Nutritional Interventions for Prevention of Iron Deficiency Anemia Among Adolescent Girls. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Gupta |
| Designation |
Ph.D. Scholar |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Room No. 111 Department of Home Science
Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9888085354 |
| Fax |
|
| Email |
shivanigupta1509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivani Gupta |
| Designation |
Ph.D. Scholar |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Room No. 111 Department of Home Science
Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9888085354 |
| Fax |
|
| Email |
shivanigupta1509@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Bala |
| Designation |
Assistant Professor |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9416468400 |
| Fax |
|
| Email |
suman_81@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University Grants Commission |
|
|
Primary Sponsor
|
| Name |
UGC NET JRF Scholarship |
| Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi Pin:110 002 |
| Type of Sponsor |
Research institution |
|
|
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 Karuna Dhingra |
Government Girls Senior Secondary School, Thanesar, Kurukshetra |
Government Girls Senior Secondary School (2413), Thanesar, Kurukshetra,136118
Kurukshetra
HARYANA |
8901891357
bondkaruna71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government Girls Senior Secondary School, Thanesar, Kurukshetra |
Approved |
| Institutional Human Ethics Committee Kurukshetra University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Subjects will not be intervened with any kind of intervention. |
| Comparator Agent |
Iron-Folic Acid
Beneficiary Group |
Subjects will be selected who will be receiving Iron & Folic acid tablets only. |
| Intervention |
Iron-Folic Acid Beneficiary and Sustainable Composite Mixture Supplemented Group |
Subjects who will be receiving Iron & Folic acid tablets will be selected and will also be intervened with developed
Sustainable Composite Mixture (SCM) based food product. |
| Intervention |
Nutrition Education and
Sustainable Composite Mixture
Supplemented Group |
Subjects will be intervened with both nutrition education and developed Sustainable Composite Mixture based food product. |
| Intervention |
Nutrition Education Group |
Subjects will be intervened with nutrition education only. |
| Intervention |
Sustainable Composite Mixture Supplemented Group |
Subjects will be intervened with developed Sustainable Composite Mixture (SCM) based food product only. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Anemic adolescent girls enrolled in school, willing to participate, and whose parents/guardians provide informed consent. |
|
| ExclusionCriteria |
| Details |
Girls with chronic illnesses such as thalassemia, sickle cell disease, chronic kidney disease etc. or those unwilling/unable to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of Nutritional Interventions. |
3 months and 6 months after the start of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate anthropometric, biochemical, clinical, and dietary status of subjects. |
Baseline (before intervention), 3 months and 6 months (after intervention). |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
08/12/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to select 180 anemic adolescent girls from schools in Kurukshetra and the study will be carried out in three phases. In Phase I (pre-intervention), data on socio-demographic profile, anthropometric measurements, biochemical parameters, clinical symptoms, and dietary intake of anemic adolescent girls will be collected using standard methods, and nutritional education tools and sustainable composite mixture-based food products will be developed. In Phase II (intervention), the experimental group will receive the nutritional interventions for six months, with data collected at baseline (0 month), mid-intervention (3 months), and at the end of the intervention (6 months). In Phase III (post-intervention), the impact of these interventions on the participants nutritional status will be assessed. |