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RecruitingNCT07921433Updated Nov 6, 2026

Iron Absorption From a Nutritional Iron Supplement

An interventional study of Iron-Enriched Hydrogel Supplement (A with breakfast) and Iron-Enriched Hydrogel Supplement (B with breakfast) in Iron Absorption and Iron Deficiencies, sponsored by ETH Zurich. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by ETH Zurich · Not applicable, Interventional, and Other

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Conventional oral iron supplements often cause gastrointestinal side effects and are limited by poor bioavailability, leaving unabsorbed iron to reach the colon. Hydrocolloid-based hydrogel matrix formulations designed for gradual iron release present a promising approach to improve iron absorption. This study evaluates fractional iron absorption (FIA) from three low-dose hydrogel formulations containing ferrous fumarate compared with ferrous fumarate without a hydrogel matrix. Test products will be administered with water, with and without a standardized breakfast. All formulations will be intrinsically labelled with stable iron isotopes ( 57Fe or 54Fe), and FIA will be determined 14 days after administration based on erythrocyte iron incorporation. In this randomized, within-subject corssover study conducted in non-anemic, iron-depleted women, each participant will receive all test conditions and serve as her own control.

02

Conditions studied

  • Iron Absorption
  • Iron Deficiencies

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03

In context

Iron Deficiencies

386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.

This study's planned enrollment of 22 is below the median of 99 across 301 interventional studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

ETH Zurich is the lead sponsor of 20 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Anemia, defined as (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 )
  • 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 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.
Terms in these criteria, in plain language(4)

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.

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.

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.

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).

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    FeHydro-A with breakfast (Condition 1)

    FeHydro-A with sodium ascorbate, consumed with a standardized breakfast

    Dietary Supplement: Iron-Enriched Hydrogel Supplement (A with breakfast)

  • Experimental
    FeHydro-B with breakfast (Condition 2)

    FeHydro-B without sodium ascorbate, consumed with a standardized breakfast

    Dietary Supplement: Iron-Enriched Hydrogel Supplement (B with breakfast)

  • Experimental
    FeHydro-A without breakfast (Condition 3)

    FeHydro-A with sodium ascorbate, consumed without breakfast

    Dietary Supplement: Iron-Enriched Hydrogel Supplement (A without breakfast)

  • Experimental
    FeHydro-B without breakfast (Condition 4)

    FeHydro-B without sodium ascorbate, consumed without breakfast

    Dietary Supplement: Iron-Enriched Hydrogel Supplement (B without breakfast)

  • Experimental
    FeHydro-C with breakfast (Condition 5)

    FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast

    Dietary Supplement: Iron-Enriched Hydrogel Supplement (C with breakfast)

  • Active comparator
    Control with breakfast (Condition 6)

    Control ferrous fumarate, consumed with a standardized breakfast

    Dietary Supplement: Control (FeFum, with breakfast)

  • Active comparator
    Control without breakfast (Condition 7)

    Control ferrous fumarate, consumed without breakfast

    Dietary Supplement: Control (FeFum, without breakfast)

Interventions

  • Dietary supplementIron-Enriched Hydrogel Supplement (A with breakfast)

    FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

    Also known as: FeHydroA

  • Dietary supplementIron-Enriched Hydrogel Supplement (B with breakfast)

    FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

    Also known as: FeHydro B

  • Dietary supplementIron-Enriched Hydrogel Supplement (A without breakfast)

    FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water

  • Dietary supplementIron-Enriched Hydrogel Supplement (B without breakfast)

    FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water

  • Dietary supplementIron-Enriched Hydrogel Supplement (C with breakfast)

    FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

  • Dietary supplementControl (FeFum, with breakfast)

    Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast

  • Dietary supplementControl (FeFum, without breakfast)

    Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water

06

What researchers measure

Primary outcomes

  1. Fractional Iron Absorption

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells

    Time frame: 14 days after administration of each labelled test condition

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be made publicly available to protect participant privacy and maintain confidentiality regarding proprietary formulation data. De-identified, aggregated study results and primary outcome data will be published in peer-reviewed scientific journals and made available via public study registries upon completion of the trial.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921433
Lead sponsor
ETH Zurich
Collaborators
Swiss Distance University of Applied Sciences
Responsible party
Nicole Stoffel (Assistant Professor, ETH Zurich) — Principal investigator
First posted
Nov 6, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Camarena
Contact
seline.camarena@pharma.ethz.ch
+41446328393

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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