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Iron Absorption From a Nutritional Iron Supplement

2. november 2026 oppdatert av: Nicole Stoffel, ETH Zurich

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sveits
    • Canton of Zurich
      • Zurich, Canton of Zurich, Sveits, 8006
        • Rekruttering
        • ETH Zürich, Laboratory of Clinical Biopharmacy
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FeHydro-A with breakfast (Condition 1)

FeHydro-A with sodium ascorbate, consumed with a standardized breakfast
Kosttilskudd: Iron-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

Andre navn:
  • FeHydroA
Eksperimentell: FeHydro-B with breakfast (Condition 2)

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

Andre navn:
  • FeHydro B
Eksperimentell: FeHydro-A without breakfast (Condition 3)

FeHydro-A with sodium ascorbate, consumed without breakfast
Kosttilskudd: Iron-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
Eksperimentell: FeHydro-B without breakfast (Condition 4)

FeHydro-B without sodium ascorbate, consumed without breakfast
Kosttilskudd: Iron-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
Eksperimentell: FeHydro-C with breakfast (Condition 5)

FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast
Kosttilskudd: Iron-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
Aktiv komparator: Control with breakfast (Condition 6)

Control ferrous fumarate, consumed with a standardized breakfast
Kosttilskudd: Control (FeFum, with breakfast)

Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast
Aktiv komparator: Control without breakfast (Condition 7)

Control ferrous fumarate, consumed without breakfast
Kosttilskudd: Control (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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fractional Iron Absorption
Tidsramme: 14 days after administration of each labelled test condition

Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells
14 days after administration of each labelled test condition

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ETH Zurich

Samarbeidspartnere

Swiss Distance University of Applied Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRONH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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