Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the… (NCT05580783) | Clinical Trial Compass
CompletedNot Applicable
Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle
Switzerland10 participantsStarted 2022-11-05
Plain-language 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. 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.
Who can participate
Age range
18 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.