Iron absorption from a hydrogel iron supplement with and without breakfast

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, within-subject crossover study compares fractional iron absorption from three hydrogel-based, low-dose iron formulations to ferrous fumarate without a hydrogel matrix. Each participant receives all test conditions and serves as her own control, with dosing given with water and with or without a standardized breakfast. Stable iron isotopes are used to trace absorption, and FIA is determined two weeks after administration by measuring erythrocyte iron incorporation. The trial enrolls non-anemic, iron-depleted women aged 18-45 and occurs at ETH Zürich with collaboration from the Swiss Distance University of Applied Sciences. Safety and eligibility criteria exclude anemia, inflammatory conditions, certain chronic diseases, recent supplement use, and pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female aged 18 to 45 years
* Plasma ferritin \<30 µg/L
* Body mass index (BMI) 18.5 kg/m2 - 24.9 kg/m2.
* Body weight \<65 kg.
* Signed informed consent
* Sufficient command of English (mother tongue or B2 level)

Exclusion Criteria:

* Anemia, defined as hemoglobin (Hb) \<120 g/L (\<12.0 g/dL).
* Elevated systemic inflammatory markers (C-reactive protein \>5.0 mg/L).
* Chronic digestive, renal and/or metabolic diseases
* Chronic medications (except for contraceptives)
* Use of vitamin, mineral, or pre-/Pprobiotic supplements in the 2 weeks before or during the study
* Blood transfusion, blood donation or significant blood loss (\>400ml) over the past 4 months
* Difficulty with blood withdrawal
* Pregnancy (tested in serum/urine) or intention to become pregnant during the course of the study
* Lactation
* Previous participation in a study using stable isotopes or participation in any clinical study within the last 30 days
* Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
* Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
* Smoking (\>1 cigarette/week)
* Vegan diet (the standardized breakfast contains plain whole milk yogurt and butter)

Special exclusion criteria for participants in the MRI imaging sub-study (n=9):

* Presence of a heart pacemaker, neurostimulator, or any other active implanted electronic device.
* Use of a hearing aid that cannot be safely removed for the MRI examination.
* Use of removable dentures that cannot be safely removed for the MRI examination.
* History of surgery on the head or heart involving implanted material that is not confirmed MRI-safe.
* Presence of metallic objects in the body (e.g. implants, magnets, metal splinters, gunshot fragments, tattoos, piercings, or surgical clips) that are not confirmed MRI-safe.
* History of metal splinter injury (e.g. ocular foreign body) or occupational exposure associated with increased risk of retained metal fragments.

Where it's running

• ETH Zürich, Laboratory of Clinical Biopharmacy
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Camarena
• Email: seline.camarena@pharma.ethz.ch
• Phone: +41446328393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.