Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorLinda Malan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ferrous sulfate
Other interventionAll participants will receive a single dose of 15 mg of iron as isotopically prepared ferrous sulfate labelled with 57Fe. The iron dose will be given with ascorbic acid to attain a molar ratio of ascorbic acid:iron of 2:1
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Living without overweight/obesityActive comparator 1 intervention
Group B: Living with overweight/obesityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Iron absorption
Long-term iron absorption will be determined in, and compared between women living without and with OW/OB in Phase 2 of the study and will be proportional to the change in the concentration of iron isotope 57 in the erythrocyte over time.
Time frame
Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)Secondary outcomes
1
Iron losses
Long-term iron losses will be determined in, and compared between women living without and with OW/OB in Phase 2 of the study and will be proportional to the change in the absolute amount of iron isotope 57 in the erythrocyte over time.
Time frame
Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)2
Iron balance
Iron balance will be calculated in and compared between women living without and with OW/OB as the difference between iron absorption and iron losses.
Time frame
Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)3
Fractional iron absorption
Fractional iron absorption from a single dose of 15 mg of isotopically-labeled iron will be compared between women living without and with OW/OB.
Time frame
Visit 2 (day 15)4
Iron status
Iron status will be determined by measuring plasma ferritin and soluble transferrin receptor.
Time frame
Screening (Ferritin only), Visits 1 (day 1), 4 (day 373), day 378, day 389 and day 394], 5 (day 429), 6 (day 485) and 7 (day 541)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Linda Malan
Lead sponsor
North-West University, South Africa
Sponsor institution
King's College London
Collaborator
ETH Zurich (Switzerland)
Collaborator
Source ClinicalTrials.gov