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ObesityRAYONNCT07081152

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

A study testing Ferrous sulfate in people with Obesity and Iron Deficiency, run by Linda Malan at 1 site in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Iron Deficiency, Inflammation
What is being tested?
Ferrous sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSouth Africa
Study dates
24 Jul 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Africa1 site, 1 recruiting
  • Esté Vorster Research Facility

    Potchefstroom, North West, 2531

    Alida Anthony, Alida.Anthony@nwu.ac.za

    Recruiting

Other trials in South Africa

About this study

Official title: Long-term Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity

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.

Read the detailed description

Adiposity-related inflammation stimulates an increase in secretion of hepcidin hormone thus limiting the absorption of iron and increasing the risk for iron deficiency (ID). In addition, the risk of anemia and/or ID in young women living with overweight (OW) or obesity (OB) is further increased by inadequate dietary intake and/or poor bioavailability of iron, as well as gastrointestinal and menstrual iron losses. Although one study quantified iron losses and absorption in young African women using the stable isotope dilution method the focus was on normal-weight women. Thus, whether women living with OW/OB can meet their iron requirements from their habitual diet remains uncertain.

This is a longitudinal study including an iron absorption study (Phase 1) and a follow-up period (Phase 2) in women living with and without OW and OB.

In phase 1, 70 healthy, mildly- and non-anemic young women living with and without OW or OB will receive a test drink labelled with 15 mg of labelled ferrous sulfate (57Fe) (Visit 1). Fractional iron absorption from the test drink will be determined by measuring the incorporation of the isotopic label into red blood cells 14 days after administration (Visit 2), and will be compared between the two groups. Participants will then undergo a one-year equilibration period. During this time, they will be contacted monthly for an electronically completed, telephonic or in-person health check, chronic medication and supplement use,, blood donation or transfusion, and whether they have fallen pregnant. In addition, they will be asked if they are on a weight-loss diet, a urine pregnancy test done and weight and haemoglobin measured once every 3-4 months. Halfway through the equilibration period we will ask participants not taking hormonal contraceptives (and not intending to do so in phase 2 of the study), to track their menstrual cycle by providing them with a monthly paper- or electronic calendar.

About 1 year after isotope administration, participants will be contacted again and screened (Visit 3) for phase 2 of the study. During this visit, a health and medical history check including the use of proton pump inhibitors,antacids, H2 blockers or iron supplements, contraceptive use and menstruation intensity will be conducted. Then, anthropometric measurements will be performed to determine BMI, and a urine sample collected for pregnancy test. If the participant qualifies to proceed with phase 2, they will be required to consume an antihelminthic dose. Phase 2 of the study will involve 4 visits (Visits 4 to 7), where they will be followed up for 6 months. During this time, blood samples will be drawn every 8 weeks for the determination of isotopic composition. In addition, iron and inflammation status will be assessed. Dietary intake will be assessed using three 24-hour recalls conducted within visits 4, 6 and 7.

Additionally, for willing participants not using hormonal contraceptives and having a regular cycle (26 to 30 days), Visit 4 (or subsequent convenient visit) will be planned to coincide with day 2 of their menstrual phase where 6 ml of blood will be drawn to quantify sex hormones, hepcidin, iron and inflammation status and IL-6. These participants will be invited again during the follicular phase (day 7), early luteal phase (day 18) and late luteal phase (day 23) for additional blood samples. For each of these sampling points, a window period of +/- 1 day will be allowed.

Being tested
Ferrous sulfate
Medical subject headings
Obesity, Iron Deficiencies, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrous sulfateOther

    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

Study groups in NCT07081152
Study groupRoleWhat they receive
Living without overweight/obesityActive comparatorParticipants with body mass index between 18 and 24.9 kg/m2
Receives: Other: Ferrous sulfate
Living with overweight/obesityExperimentalParticipants with body mass index equal to or greater than 28 kg/m2
Receives: Other: Ferrous sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (18)
  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.

    Measured: 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.

    Measured: 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.

    Measured: Visit 2 (day 15)

  4. Iron status

    Iron status will be determined by measuring plasma ferritin and soluble transferrin receptor.

    Measured: 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)

  5. Inflammation status

    Inflammation status will be determined by measuring plasma C-reactive protein (CRP) and alpha-1-acid glycoprotein.

    CRP will also be used to assess the absence or presence of low-grade inflammation at screening for phase 1 and visit 3, using a cut-off of <2 mg/l and 2-20 mg/l, respectively.

    Measured: 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)

  6. Dietary iron intake

    Dietary iron intake will be assessed using 3 x 24 hr recalls within visits 4, 6 and 7.

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

  7. Laboratory comparison of measurement of red blood cell isotope concentrations

    Iron isotope concentration measurements will be compared between the laboratories at North-West University and the Swiss Federal Institute of Technology Zurich.

    Measured: Visit 2 (day 15), 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)

  8. Dietary intake of iron absorption enhancers

    Dietary intake of iron absorption enhancers like vitamin C will be determined using 3 x 24-h recalls questionnaire conducted within the scheduled visit

    Measured: Visits 4 (day 373), 6 (day 485) and 7 (day 541)

  9. Dietary intake of iron absorption inhibitors

    Dietary intake of iron absorption inhibitors like phytic acid will be determined using 3 x 24-h recalls questionnaire conducted within the scheduled visit

    Measured: Visits 4 (day 373), 6 (day 485) and 7 (day 541)

  10. Body fat percentage

    Body fat percentage will be assessed using the deuterium dilution technique and/or bioelectrical impedance analysis or the bodpod

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

  11. Waist circumference

    Waist circumference will be measured as an indicator of body fat distribution.

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

  12. Hip circumference

    Hip circumference will be measured as an indicator of body fat distribution.

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

  13. Liver function

    Liver function will be assessed by measuring alanine transaminase and aspartate transaminase enzymes.

    Measured: Screening

  14. Gut inflammation

    Gut inflammation will be assessed by measuring gut integrity and inflammation biomarkers namely Intestinal fatty acid-binding protein (IFABP) and soluble cluster of differentiation 14 (sCD14).

    Measured: Screening

  15. Menstruation intensity

    Menstruation intensity will be assessed using a self-administered health diary

    Measured: Day 373 to day 541

  16. Haemoglobin

    Haemoglobin measurement will be compared between a point-of-care device (Hemocue) and an automated haematology analyser

    Measured: Screening

  17. Oestradiol

    17-beta oestradiol will be measured on days 2, 7, 18 and 23 of the menstrual cycle. The day 2 sample will align with visit 4 or the next convenient scheduled visit.

    Measured: Visit 4 (day 373), day 378, day 389 and day 394

  18. Progesterone

    Progesterone will be measured on days 2, 7, 18 and 23 of the menstrual cycle. The day 2 sample will align with visit 4 or the next convenient scheduled visit.

    Measured: Visit 4 (day 373), day 378, day 389 and day 394

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start24 Jul 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07081152
Sponsor's protocol ID
RAYON
Other IDs
26891
Acronym
RAYON
Status last verified
Mar 2026
First submitted
3 Jul 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ferrous sulfate in people with Obesity and Iron Deficiency, run by Linda Malan at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary Uyoga, PhD (+27 18 299 4237, 44645104@mynwu.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iron absorption (time frame: Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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