CompletedNot Applicable

Different Efficacy of IFA Supplementation Among Obese and Non-obese Women

Indonesia165 participantsStarted 2024-08-01

Plain-language summary

This clinical trial aims to learn if there is a relationship between OWT/OB and IDA in nonpregnant women of reproductive age and its impact on iron supplementation. The main questions it aims to answer are: * Is there any independent association between overweight/obesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors? * Does the effect of iron supplementation on iron status vary between overweight/obese and normal-weight nonpregnant women (as measured by multiple iron biomarkers)? Researchers will compare several biomarkers between the case and control groups after the intervention is given for 90 days. Participants will: * Visit the research center before the intervention given and after 90 days * Take daily iron-folic acid supplements for 90 days * Keep a diary of their supplement's intake

Who can participate

Age range

20 Years – 29 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nonpregnant, nonlactating women aged 19 - 29 years * Never been married and pregnant. * Having no menstrual abnormality (amenorrhea, polymenorrhea, etc.) * Able to read and write in Bahasa Indonesia * Not undergoing body mass reduction or on any particular weight loss diet Exclusion Criteria: * BMI \<18.5 kg/m2 * Self-reported specific diseases that need diet modification (i.e., type 1 diabetes, kidney disease, autoimmune disease, etc.) * Self-report of significant medical conditions (e.g., diabetes mellitus, disorders of the liver \[including hemochromatosis\] and kidney, autoimmune or metabolic diseases, and malignancy\] or use of medications that may influence weight, iron, or inflammatory status; pregnancy or lactation; vegetarianism; zinc supplementation; smoking habit.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Iron Deficiency Anemia (IDA)

Timeframe: From enrollment to the end of treatment at 90 days

Concentration of Hemoglobin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of Ferritin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of Hepcidin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Overweight and obese prevalence

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of CRP

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of AGP-1

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Trial details

NCT IDNCT06622551

SponsorGriffith University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Obesity and Overweight trials

Plain-language summary

Who can participate

Age range

20 Years – 29 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with Iron Deficiency Anemia (IDA)

Timeframe: From enrollment to the end of treatment at 90 days

Concentration of Hemoglobin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of Ferritin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of Hepcidin

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Overweight and obese prevalence

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of CRP

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)

Concentration of AGP-1

Timeframe: Day 0 (Before intervention) and Day 90 (After intervention)