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

NCT07081152 | Recruiting DMC

• 2 other identifiers: RAYON26891
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Iron Deficiency; Inflammation

Outcome Measures

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.

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

Secondary Outcomes (18)

• Iron losses

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

• Iron balance

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

• Fractional iron absorption

  Visit 2 (day 15)

• Iron status

  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)

• Inflammation status

  Screening (CRP only), Visit 1 (day 1), 3 (day 366;CRP only), day 378, day 389 and day 394] 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)

Study Arms (2)

Living without overweight/obesity

ACTIVE COMPARATOR

Participants with body mass index between 18 and 24.9 kg/m2

Other: Ferrous sulfate

Living with overweight/obesity

EXPERIMENTAL

Participants with body mass index equal to or greater than 28 kg/m2

Other: Ferrous sulfate

Interventions

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

Living with overweight/obesity; Living without overweight/obesity

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 participants living with OW/OB
• Planning to reside in the study area for at least 2 years

You may not qualify 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
• 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
• 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

Sponsors & Collaborators

• Linda Malan: lead
• King's College London: collaborator
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

Esté Vorster Research Facility

Potchefstroom, North West, 2531, South Africa

RECRUITING

MeSH Terms

Conditions

Obesity; Iron Deficiencies; Inflammation

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• Linda Malan, PhD

  Centre of Excellence for Nutrition, North-West University

  PRINCIPAL INVESTIGATOR

• Mary Uyoga, PhD

  Centre of Excellence for Nutrition, North-West University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Uyoga, PhD

CONTACT

+27 18 299 4237; 44645104@mynwu.ac.za

Linda Malan, PhD

CONTACT

+27 18 299 4237; Linda.Malan@nwu.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ZA (1)