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Iron Absorption From a Nutritional Iron Supplement

2. november 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Schweiz
    • Canton of Zurich
      • Zurich, Canton of Zurich, Schweiz, 8006

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FeHydro-A with breakfast (Condition 1)

FeHydro-A with sodium ascorbate, consumed with a standardized breakfast
Kosttilskud: 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 navne:
  • FeHydroA
Eksperimentel: FeHydro-B with breakfast (Condition 2)

FeHydro-B without sodium ascorbate, consumed with a standardized breakfast
Kosttilskud: 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 navne:
  • FeHydro B
Eksperimentel: FeHydro-A without breakfast (Condition 3)

FeHydro-A with sodium ascorbate, consumed without breakfast
Kosttilskud: 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
Eksperimentel: FeHydro-B without breakfast (Condition 4)

FeHydro-B without sodium ascorbate, consumed without breakfast
Kosttilskud: 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
Eksperimentel: FeHydro-C with breakfast (Condition 5)

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ETH Zurich

Samarbejdspartnere

Swiss Distance University of Applied Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

2. november 2026

Først indsendt, der opfyldte QC-kriterier

2. november 2026

Først opslået (Faktiske)

6. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRONH

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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