Iron-deficiencyMBL_AbsNCT05580783
Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle
A study testing Test meal labelled with 54Fe, Test meal labelled with 57Fe and Test meal labelled with 58Fe in people with Iron-deficiency, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Test meal labelled with 54Fe, Test meal labelled with 57Fe and Test meal labelled with 58Fe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Nov 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18-30 years old
- Weight <70 kg
- Normal body mass index (18.5 - 25kg/m2)
- Regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months)
- Depleted iron stores (serum ferritin ≤ 30 µg/L)
- Signed informed consent
- Able to read and understand English
Who cannot join
- Use of hormonal contraceptives within a 3-month recall period
- Anemia (hemoglobin < 117 g/L)
- Any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement)
- Women with severe menstrual cramps that would prevent them from attending study meetings during menstruation (judged by the women)
- Consumption of iron-containing supplements within 1 month prior to the start of study
- Known difficulties with blood sampling
Show all 10Show fewer
- Pregnancy (serum human chorionic gonadotropin (hCG) < 5 mIU/mL)
- Current smoking (>1 cigarette per week over a 1-month recall period)
- Women who are planning to get pregnant within the study period, as this would affect iron metabolism and subsequent study measurements.
- Inability to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle
Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.
Read the detailed description
To date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. Although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. A better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency
- Conditions
- Iron-deficiency
- Being tested
- Test meal labelled with 54Fe, Test meal labelled with 57Fe, Test meal labelled with 58Fe
- Keywords
- Anemia, Micronutrients, Iron, Trace elements, Menstruation, Hormones
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal labelled with 54FeOther
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
Test meal labelled with 57FeOther
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
Test meal labelled with 58FeOther
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe
| Study group | Role | What they receive |
|---|---|---|
| Experimental 54Fe | Experimental | Participants will receive 54Fe at two time points throughout their menstrual cycle. Receives: Other: Test meal labelled with 54Fe |
| Experimental 57Fe | Experimental | Participants will receive 57Fe at two time points throughout their menstrual cycle. Receives: Other: Test meal labelled with 57Fe |
| Experimental 58Fe | Experimental | Participants will receive 58Fe at two time points throughout their menstrual cycle. Receives: Other: Test meal labelled with 58Fe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption (%)
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals.
Measured: Day 2, 18, 22, 26 and 40
Secondary outcomes (11)
Hemoglobin concentration (g/L)
Haemoglobin will be measured to determine presence of anaemia
Measured: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
Serum ferritin (microg/L)
Iron status parameter
Measured: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum transferrin receptor (mg/L)
Iron status parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum iron (microg/mL)
Iron status parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum hepcidin (nmol/L)
Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Alpha-1-acid glycoprotein (g/L)
Chronic inflammation parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
C-reactive protein (mg/L)
Acute inflammation parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum estradiol (pg/mL)
Hormonal parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum progesterone (ng/mL)
Hormonal parameter
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Total iron binding capacity (microg/mL)
Total iron binding capacity will be measured to determine the presence of iron deficiency
Measured: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Menstrual blood volume loss/cycle
Semi-quantitative assessment to measure menstrual blood loss per cycle
Measured: Menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start5 Nov 2022
- Primary completion6 Jan 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Sight and Life Foundation, Kamuzu University of Health Sciences
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580783
- Sponsor's protocol ID
- MBL_Abs
- Other IDs
- IZSTZ0_208432/1
- Acronym
- MBL_Abs
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT05580783
- Acronym / sponsor ID
- MBL_Abs / MBL_Abs
- Conditions
- Iron-deficiency
- Keywords
- Anemia, Micronutrients, Iron, Trace elements, Menstruation, Hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Sight and Life Foundation, Kamuzu University of Health Sciences
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Oct 2022 (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.
Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.
Detailed description
To date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. Although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. A better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 54Fe | Experimental | Other: Test meal labelled with 54FeParticipants will receive 54Fe at two time points throughout their menstrual cycle. |
| Experimental 57Fe | Experimental | Other: Test meal labelled with 57FeParticipants will receive 57Fe at two time points throughout their menstrual cycle. |
| Experimental 58Fe | Experimental | Other: Test meal labelled with 58FeParticipants will receive 58Fe at two time points throughout their menstrual cycle. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, 18-30 years old
- Weight <70 kg
- Normal body mass index (18.5 - 25kg/m2)
- Regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months)
- Depleted iron stores (serum ferritin ≤ 30 µg/L)
Key exclusion criteria (10 listed)
- Use of hormonal contraceptives within a 3-month recall period
- Anemia (hemoglobin < 117 g/L)
- Any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement)
- Women with severe menstrual cramps that would prevent them from attending study meetings during menstruation (judged by the women)
- Consumption of iron-containing supplements within 1 month prior to the start of study
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 |
|---|---|---|
| Test meal labelled with 54FeEach participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe | Other | Experimental 54Fe |
| Test meal labelled with 57FeEach participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe | Other | Experimental 57Fe |
| Test meal labelled with 58FeEach participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe | Other | Experimental 58Fe |
Primary outcome
Fractional iron absorption (%)
Time frame: Day 2, 18, 22, 26 and 40
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals.
11 secondary outcomes
Hemoglobin concentration (g/L)
Time frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
Serum ferritin (microg/L)
Time frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum transferrin receptor (mg/L)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum iron (microg/mL)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum hepcidin (nmol/L)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Alpha-1-acid glycoprotein (g/L)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
C-reactive protein (mg/L)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum estradiol (pg/mL)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum progesterone (ng/mL)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Total iron binding capacity (microg/mL)
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Menstrual blood volume loss/cycle
Time frame: Menstruation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal labelled with 54Fe, Test meal labelled with 57Fe and Test meal labelled with 58Fe in people with Iron-deficiency, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (%) (time frame: Day 2, 18, 22, 26 and 40). 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 22 Nov 2023.