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.
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
- Recruiting
Esté Vorster Research Facility
Potchefstroom, North West, 2531
Alida Anthony, Alida.Anthony@nwu.ac.za
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.
- Conditions
- Obesity, Iron Deficiency, Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Living without overweight/obesity | Active comparator | Participants with body mass index between 18 and 24.9 kg/m2 Receives: Other: Ferrous sulfate |
| Living with overweight/obesity | Experimental | Participants 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Liver function
Liver function will be assessed by measuring alanine transaminase and aspartate transaminase enzymes.
Measured: Screening
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
Menstruation intensity
Menstruation intensity will be assessed using a self-administered health diary
Measured: Day 373 to day 541
Haemoglobin
Haemoglobin measurement will be compared between a point-of-care device (Hemocue) and an automated haematology analyser
Measured: Screening
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
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.
- First posted23 Jul 2025
- Study start24 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Linda Malan
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, ETH Zurich (Switzerland)
- Responsible party
- Sponsor-investigator, Linda Malan, North-West University, South Africa
- Investigators
- Linda Malan, PhD, Principal investigator, Centre of Excellence for Nutrition, North-West UniversityMary Uyoga, PhD, Principal investigator, Centre of Excellence for Nutrition, North-West University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07081152
- Acronym / sponsor ID
- RAYON / RAYON
- Conditions
- Obesity, Iron Deficiency, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Linda MalanUniversity, hospital or other
- Collaborators
- King's College London, ETH Zurich (Switzerland)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living without overweight/obesity | Active comparator | Other: Ferrous sulfateParticipants with body mass index between 18 and 24.9 kg/m2 |
| Living with overweight/obesity | Experimental | Other: Ferrous sulfateParticipants with body mass index equal to or greater than 28 kg/m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateAll 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 | Other | Living with overweight/obesity, Living without overweight/obesity |
Primary outcome
Iron absorption
Time frame: Visits 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.
18 secondary outcomes
Iron losses
Time frame: Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Iron balance
Time frame: Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Fractional iron absorption
Time frame: Visit 2 (day 15)
Iron status
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)
Inflammation status
Time frame: 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)
Dietary iron intake
Time frame: Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Laboratory comparison of measurement of red blood cell isotope concentrations
Time frame: Visit 2 (day 15), 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Dietary intake of iron absorption enhancers
Time frame: Visits 4 (day 373), 6 (day 485) and 7 (day 541)
Dietary intake of iron absorption inhibitors
Time frame: Visits 4 (day 373), 6 (day 485) and 7 (day 541)
Body fat percentage
Time frame: Screening, Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Waist circumference
Time frame: Screening, Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Hip circumference
Time frame: Screening, Visits 4 (day 373), 5 (day 429), 6 (day 485) and 7 (day 541)
Liver function
Time frame: Screening
Gut inflammation
Time frame: Screening
Menstruation intensity
Time frame: Day 373 to day 541
Haemoglobin
Time frame: Screening
Oestradiol
Time frame: Visit 4 (day 373), day 378, day 389 and day 394
Progesterone
Time frame: Visit 4 (day 373), day 378, day 389 and day 394
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
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.