Omega-3 Fatty Acid Supplementation and Fractional Iron Absorption in Obese South African Women (NCT05220735) | Clinical Trial Compass
CompletedNot Applicable
Omega-3 Fatty Acid Supplementation and Fractional Iron Absorption in Obese South African Women
South Africa33 participantsStarted 2022-03-07
Plain-language summary
In South Africa the prevalence of obesity in women of reproductive age is high; these women also have a high risk for iron deficiency (ID). Obesity is associated with low-grade systemic inflammation, which was shown to increase the expression of hepcidin, leading to a reduction in duodenal iron absorption. Thus, alleviating the sub-clinical inflammation associated with obesity could improve iron absorption and status. Supplementation with n-3 long-chain polyunsaturated fatty acids (LCPUFA) has been shown to reduce inflammation in obese individuals. A stable iron isotope study will be performed to investigate the effect of n-3 LCPUFA supplementation on fractional iron absorption in obese South African women.
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:
* Self-classified women from African descent and of reproductive age (18 - 35 years)
* BMI ≥ 28kg/m2 (indicating obesity)
* Midly- or non-anaemic (Hb ≥11 g/dl)
* Low n-3 LCPUFA status (RBC omega-3 index \< 6%)
* Low grade systemic inflammation (HS-CRP ≥ 2 mg/l but ≤ 20 mg/l)
* Be able to read and understand English
Exclusion Criteria:
* Treated chronic disease or gastrointestinal disorders
* Regular use of medication (except oral contraceptives, others after approval by the investigator) and women receiving treatment for high blood pressure
* Current consumption of iron or n-3 LCPUFA or ascorbic acid-containing supplements other than the supplements provided (Participants will be asked to discontinue use three weeks prior to enrolment)
* Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
* Pregnancy or lactation
* Subjects who cannot be expected to comply with the study protocol
* Subjects who are smoking
* Difficulty drawing blood due to poor quality veins
* Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood
* Subjects with fish allergies
* Participants who plan to start or stop the use of contraceptives in the following 4 months.
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
1
Fractional iron absorption (%)
Timeframe: Change between baseline and 3 months (days 17 and 118)