Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Ob… (NCT07081152) | Clinical Trial Compass
RecruitingNot Applicable
Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
South Africa70 participantsStarted 2025-07-24
Plain-language summary
Young women living with obesity (OB) have a greater risk of developing iron deficiency. Plus, the risk of anemia and/or ID in young women living with overweight (OW) and obesity (OB) is further increased by inadequate dietary intake and/or poor bioavailability of iron, as well as gastrointestinal and menstrual iron losses. It is not certain whether women living with OW/OB can meet their iron requirements from their day-to-day diet.
The aim of this study is to compare iron absorption and losses over a long period between women living with and without OW and OB. Secondary outcomes include iron and inflammation status, as well as dietary iron intake.
Who can participate
Age range
18 Years – 35 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:
* Of African descent
* BMI of 18.5 to 24.9 kg/m2 for participants living without OW/OB and BMI ≥ 28 kg/m2 for participants living with OW/OB
* Having low to moderate inflammation-adjusted iron stores (ferritin ≤50 µg/L)
* Absence of low-grade inflammation (CRP\<2 mg/l) for participants living without OW/OB and presence of low-grade inflammation CRP 2-20 mg/l) for participants living with OW/OB
* Planning to reside in the study area for at least 2 years
Exclusion Criteria:
* Hemoglobin \< 11 g/dl
* Treated or self-reported chronic or malabsorptive disorder
* Current use of chronic anti-inflammatory medication, like corticosteroids or non-steroidal anti-inflammatory medication
* Pregnancy or planning to become pregnant in the next 2 years
* Lactation
* Fear of needles or experiencing vaso-vagal episodes when exposed to blood
* Difficulty drawing blood due to poor quality veins
* Blood donation in the past 4 months or plans to donate blood during the study
* On a weight-loss diet or program or planning to start the same during the study
* Smoking
* Unwillingness to stop taking iron and /or vitamin C-containing supplements during phase 1 of the study
* Regular use of antacids, proton pump inhibitors or H2 blockers
Additional inclusion criteria applicable to phase 2 of the study
* Labelled with stable iron isotope (tracer) for a minimum of one year
* Willingness not to start or stop contraceptive use during the 6 months
* BMI ≥ 18.5 to 24.9 kg/m2 for parti…
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.