Iron Absorption From a Nutritional Iron Supplement
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Suplemento dietético: Iron-Enriched Hydrogel Supplement (A with breakfast)
- Suplemento dietético: Iron-Enriched Hydrogel Supplement (B with breakfast)
- Suplemento dietético: Iron-Enriched Hydrogel Supplement (A without breakfast)
- Suplemento dietético: Iron-Enriched Hydrogel Supplement (B without breakfast)
- Suplemento dietético: Iron-Enriched Hydrogel Supplement (C with breakfast)
- Suplemento dietético: Control (FeFum, with breakfast)
- Suplemento dietético: Control (FeFum, without breakfast)
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Camarena
- Número de teléfono: +41446328393
- Correo electrónico: seline.camarena@pharma.ethz.ch
Ubicaciones de estudio
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Canton of Zurich
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Zurich, Canton of Zurich, Suiza, 8006
- Reclutamiento
- ETH Zürich, Laboratory of Clinical Biopharmacy
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Contacto:
- Camarena
- Número de teléfono: +41446328393
- Correo electrónico: seline.camarena@pharma.ethz.ch
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: FeHydro-A with breakfast (Condition 1)
FeHydro-A with sodium ascorbate, consumed with a standardized breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
Otros nombres:
|
|
Experimental: FeHydro-B with breakfast (Condition 2)
FeHydro-B without sodium ascorbate, consumed with a standardized breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
Otros nombres:
|
|
Experimental: FeHydro-A without breakfast (Condition 3)
FeHydro-A with sodium ascorbate, consumed without breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
Experimental: FeHydro-B without breakfast (Condition 4)
FeHydro-B without sodium ascorbate, consumed without breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
Experimental: FeHydro-C with breakfast (Condition 5)
FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast |
FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
Comparador activo: Control with breakfast (Condition 6)
Control ferrous fumarate, consumed with a standardized breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
Comparador activo: Control without breakfast (Condition 7)
Control ferrous fumarate, consumed without breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fractional Iron Absorption
Periodo de tiempo: 14 days after administration of each labelled test condition
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRONH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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