Actively Recruiting
Long-term Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
Led by Linda Malan · Updated on 2026-03-23
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Linda Malan
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Young women living with overweight (OW) or obesity (OB) face a higher risk of iron deficiency and anemia due to factors like inadequate dietary iron intake, poor iron bioavailability, and iron losses from menstruation and the gastrointestinal tract. This research evaluates iron absorption and losses over a long period in young South African women living with and without OW or OB. It also studies iron and inflammation status and dietary iron intake as important secondary outcomes. The study is a longitudinal interventional trial with two phases. In phase 1, 70 healthy, mildly- and non-anemic women receive a single test drink containing a 15 mg dose of isotopically labelled ferrous sulfate with ascorbic acid. Iron absorption is measured by the incorporation of the isotope into red blood cells 14 days later. After a one-year equilibration period with monthly health checks and periodic assessments, phase 2 begins with screening and an antihelminthic dose. During phase 2, participants attend four visits over six months for blood samples, dietary recalls, and iron and inflammation assessments, with additional hormonal and inflammatory testing for some participants at specific menstrual cycle phases. Participants are involved in regular health monitoring, including weight, hemoglobin, and pregnancy tests. Researchers collect blood samples at multiple visits to analyze iron absorption, losses, balance, and status, as well as inflammation markers. Dietary intake is tracked through recalls, and body composition and anthropometric measures are recorded. The study includes detailed menstrual cycle tracking for eligible participants. Outcomes focus on iron absorption and losses, with safety and health monitored throughout, and total participation spans over one year and six months during the two study phases.
CONDITIONS
Brief Title
Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Of African descent
- Female aged 18 to 35 years
- BMI of 18.5 to 24.9 kg/m2 for participants without overweight/obesity
- BMI equal to or greater than 28 kg/m2 for participants with overweight/obesity
- Low to moderate inflammation-adjusted iron stores (ferritin 30 �b5g/L)
- Absence of low-grade inflammation (CRP <2 mg/l) for participants without overweight/obesity
- Presence of low-grade inflammation (CRP 2-20 mg/l) for participants with overweight/obesity
- Planning to reside in the study area for at least 2 years
You will not qualify if you...
- Hemoglobin less than 11 g/dl
- Chronic or malabsorptive disorders, treated or self-reported
- Current use of chronic anti-inflammatory medication such as corticosteroids or NSAIDs
- Pregnancy or planning pregnancy within 2 years
- Lactation
- Fear of needles or vaso-vagal episodes during blood draws
- Difficulty drawing blood due to poor vein quality
- Blood donation in past 4 months or planning donation during study
- On or planning to start a weight-loss diet or program during the study
- Smoking
- Unwillingness to stop taking iron or vitamin C supplements during phase 1
- Regular use of antacids, proton pump inhibitors, or H2 blockers
- Blood transfusion, intravenous iron infusion, blood donation, or significant blood loss during equilibration period (phase 2)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive a single dose of labeled ferrous sulfate. Iron absorption is measured by blood samples taken 14 days later.
2 visits (in-person)
Duration - 1 year
Participants are contacted monthly for health checks and assessed every 3-4 months for weight, haemoglobin, and pregnancy status over one year.
Monthly contacts and assessments every 3-4 months
Duration - 1 visit (in-person)
Participants are screened again to confirm eligibility for phase 2, including health history, BMI measurement, and pregnancy testing.
1 visit (in-person)
Duration - 6 months
Participants are followed for 6 months with blood samples every 8 weeks to assess iron absorption, iron losses, inflammation, and dietary intake. Additional blood samples are collected for hormonal and iron status assessments timed with menstrual phases for some participants.
4 visits every 8 weeks (in-person), plus additional visits for menstrual cycle blood sampling as applicable
Trial Site Locations
Total: 1 location
1
Esté Vorster Research Facility
Potchefstroom, North West, South Africa, 2531
Actively Recruiting
Research Team
M
Mary Uyoga, PhD
L
Linda Malan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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