Clinical trial

Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07081152

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 35 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity, Iron Deficiency, Inflammation

Full registry criteria

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

Treatments and study arms

Ferrous sulfate

Other

All 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

Primary outcomes

Iron absorptionVisits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)

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.

Study locations

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Esté Vorster Research Facility🇿🇦 Potchefstroom, North West, South Africa

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Alida AnthonyContact