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Search / Trial NCT07081152

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

Launched by LINDA MALAN · Jul 14, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how young South African women absorb and lose iron, especially comparing those who have a healthy weight to those who are overweight or living with obesity. Iron is important because it helps carry oxygen in the blood, and having too little iron can lead to anemia, which makes people feel tired and weak. Women with overweight or obesity might have a higher risk of iron deficiency because of factors like diet, body inflammation, and iron lost during menstruation. The study aims to understand if women in these groups can get enough iron from their daily diet and how their bodies handle iron over time.

Women who might be eligible for this study are those of African descent, between a healthy weight or overweight/obese based on their body mass index (BMI), and with certain levels of iron and inflammation in their blood. Participants need to be planning to stay in the study area for at least two years and should not be pregnant, breastfeeding, or have certain health conditions like anemia or chronic illnesses. During the study, participants can expect to have blood tests and provide information about their diet and health. The study is not yet recruiting, but it hopes to learn important information that could help improve iron health in young women with different body weights.

Gender

FEMALE

Eligibility 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
  • 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

About Linda Malan

Linda Malan is a clinical trial sponsor with a commitment to advancing medical research through the support and oversight of innovative clinical studies. With a focus on ensuring rigorous adherence to regulatory standards and ethical practices, Linda Malan facilitates the development of safe and effective therapeutic interventions aimed at improving patient outcomes.

Locations

Patients applied

0 patients applied

Trial Officials

Linda Malan, PhD

Principal Investigator

Centre of Excellence for Nutrition, North-West University

Mary Uyoga, PhD

Principal Investigator

Centre of Excellence for Nutrition, North-West University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported