Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
Recruiting · NCT07081152 · Interventional (participants receive a specific treatment) · Lead sponsor: Linda Malan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 participants living without OW/OB and BMI ≥ 28 kg/m2 for participants living with OW/OB
- Additional exclusion criteria applicable to phase 2 of the study
- \- Blood transfusion, intravenous iron infusion, blood donation or significant blood loss during the equilibration period
Where it is running
1 location listed.
- Esté Vorster Research Facility - Potchefstroom, North West, South Africa