| CTRI Number |
CTRI/2025/08/092137 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing dietary iron intake among vegetarian and non-vegetarian young adult women using dietary assessment tools |
|
Scientific Title of Study
|
Iron Intake in Vegetarian and Non-vegetarian Females (20-25 years): A Comparison across BMI Categories and Socio-economic Status using Three Dietary Assessment Tools. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ifra Shaikh |
| Designation |
student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9619624601 |
| Fax |
|
| Email |
shaikhifra1426@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
MMP Shah College |
| Address |
MMP Shah college, Divya Rishi Apartment, 338, R.A Kidwai Marg, Matunga East, Mumbai Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
MMP Shah College |
| Address |
MMP Shah college, Divya Rishi Apartment, 338, R.A Kidwai Marg, Matunga East, Mumbai Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Ifra Shaikj |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019 |
| 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 |
| Ifra Shaikh |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA |
9619624601
shaikhifra1426@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no disease conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
observational study, no intervention is involved |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 20 to 25 years residing in Mumbai Metropolitan Region and Thane district, belonging to middle income group. participants should be following vegetarian or nonvegetarian diet for at least one year. must be willing to share dietary information and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women, individuals on iron supplements, those with chronic infections in the past six months (e.g., tuberculosis, malaria), and individuals with non-communicable diseases such as diabetes mellitus, kidney disorders, or liver disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the average dietary iron intake (total, heme, and non-heme) among vegetarian and non-vegetarian females aged 20–25 years, across different BMI categories and socio-economic statuses. |
Dietary iron intake will be assessed once at baseline, using the 3-Day Dietary Record, Food Frequency Questionnaire, and Minimum Dietary Diversity for Women (MDD-W). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the influence of dietary enhancers (vitamin C, vitamin A) & inhibitors (phytates, polyphenols, calcium, tea/coffee) on iron bioavailability. |
These factors will be assessed once at baseline, at the time of dietary assessment using the 3-Day Dietary Record (3DDR) & Food Frequency Questionnaire (FFQ). |
|
|
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)
|
10/08/2025 |
| 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="0"
Months="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This observational cross-sectional study aims to assess and compare the iron intake among vegetarian and non-vegetarian females aged 20–25 years residing in Mumbai and Thane regions. A total of 200 participants will be included. The study will evaluate dietary iron intake using three dietary assessment tools, 3Day Dietary Record, Food Frequency Questionnaire, and Minimum Dietary Diversity for Women. The study will also assess the influence of BMI and socio-economic status on iron intake and bioavailability. Factors such as dietary enhancers and inhibitors will be analyzed to understand their effect on iron absorption. No intervention is involved in the study. |