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Official title Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
ClinicalTrials.gov ID: NCT07081152
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Planning to reside in the study area for at least 2 years
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Potchefstroom, North West, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Potchefstroom, North West, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.