An interventional study of Test meal labelled with 54Fe and Test meal labelled with 57Fe in Iron-deficiency, sponsored by Isabelle Herter-Aeberli. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Isabelle Herter-Aeberli · Not applicable, Interventional, and Basic science
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.
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
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Isabelle Herter-Aeberli is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 54Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 54Fe
Participants will receive 57Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 57Fe
Participants will receive 58Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 58Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe
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.
Time frame: Day 2, 18, 22, 26 and 40
Hemoglobin concentration (g/L)
Haemoglobin will be measured to determine presence of anaemia
Time frame: 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
Time frame: 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
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum iron (microg/mL)
Iron status parameter
Time frame: 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
Time frame: 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
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
C-reactive protein (mg/L)
Acute inflammation parameter
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum estradiol (pg/mL)
Hormonal parameter
Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum progesterone (ng/mL)
Hormonal parameter
Time frame: 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
Time frame: 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
Time frame: Menstruation
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Jan 2023, 2 months.
Of 132 non-industry interventional studies with no phase under Anemia, Iron-Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 2 months is below that.
Counting every sponsor, half of 141 studies reached it within 11 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Isabelle Herter-Aeberli