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Iron Absorption From Plant Heme Iron

NCT ID: NCT07143890

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2025-12-18

Brief Summary

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Heme, an iron protoporphyin IX complex, consists of a ferrous ion captured in a porphyrin ring acting as a tetradentate ligand. The unique features of heme iron -its unusually high absorption in foods and its resistance to luminal inhibitors of iron absorption- make it a potentially interesting iron fortificant. This study aims to compare fractional iron absorption from two plant-derived heme iron compounds-iron chlorophyllin and soy hemoglobin-with ferrous sulfate (negative control) and porcine hemoglobin (positive control) in iron-deficient women. All four compounds will be intrinsically labeled with stable iron isotopes. Fractional absorption will be assessed 14 days after test meal administration via erythrocyte iron incorporation.

Absorption will be tested in two matrices: water and maize porridge (an inhibitory matrix). Each participant will consume all test conditions in a randomized order, allowing for within-subject comparisons.

Detailed Description

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Conditions

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Iron Deficiency (ID) Iron Absorption

Keywords

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Iron sulfate Iron fortification plant-derived heme iron Stable isotopes Iron bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Iron chlorophyllin + Water

3 mg iron as Fe chlorophyllin (54Fe) + water

Group Type EXPERIMENTAL

Iron chlorophyllin + no-matrix

Intervention Type OTHER

Water with labelled Fe chlorophyllin (54Fe)

Soy hemoglobin + Water

3 mg iron as soy hemoglobin (58Fe) + water

Group Type EXPERIMENTAL

SoyHb + no-matrix

Intervention Type OTHER

Water with labelled soy hemoglobin (58Fe)

Ferrous sulfate + Water (negative control)

3 mg iron as ferrous sulfate (58Fe) + water

Group Type ACTIVE_COMPARATOR

FeSO4 + no-matrix

Intervention Type OTHER

Water with labelled ferrous sulfate (58Fe)

Porcine hemoglobin + Water (positive control)

3 mg iron as porcine hemoglobin (57Fe) + water

Group Type ACTIVE_COMPARATOR

Hb + no-matrix

Intervention Type OTHER

Water with labelled porcine hemoglobin (57Fe)

Iron Chlorophyllin + Inhibitory Meal

3 mg iron as Fe chlorophyllin (54Fe) + maize porridge

Group Type EXPERIMENTAL

Iron chlorophyllin + meal-matrix

Intervention Type OTHER

Maize porridge with labelled Fe chlorophyllin (54Fe)

Soy Hemoglobin + Inhibitory Meal

3 mg iron as soy hemoglobin (58Fe) + maize porridge

Group Type EXPERIMENTAL

SoyHb + meal-matrix

Intervention Type OTHER

Maize porridge with labelled soy hemoglobin (58Fe)

Ferrous sulfate + Inhibitory Meal (negative control)

3 mg iron as ferrous sulfate (57Fe) + maize porridge

Group Type ACTIVE_COMPARATOR

FeSO4 + meal-matrix

Intervention Type OTHER

Maize porridge with labelled ferrous sulfate (57Fe)

Porcine hemoglobin + Inhibitory Meal (positive control)

3 mg of iron as porcine hemoglobin (57Fe) + maize porridge

Group Type ACTIVE_COMPARATOR

Hb + meal-matrix

Intervention Type OTHER

Maize porridge with labelled porcine hemoglobin (57Fe)

Interventions

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Iron chlorophyllin + no-matrix

Water with labelled Fe chlorophyllin (54Fe)

Intervention Type OTHER

SoyHb + no-matrix

Water with labelled soy hemoglobin (58Fe)

Intervention Type OTHER

FeSO4 + no-matrix

Water with labelled ferrous sulfate (58Fe)

Intervention Type OTHER

Hb + no-matrix

Water with labelled porcine hemoglobin (57Fe)

Intervention Type OTHER

Iron chlorophyllin + meal-matrix

Maize porridge with labelled Fe chlorophyllin (54Fe)

Intervention Type OTHER

SoyHb + meal-matrix

Maize porridge with labelled soy hemoglobin (58Fe)

Intervention Type OTHER

FeSO4 + meal-matrix

Maize porridge with labelled ferrous sulfate (57Fe)

Intervention Type OTHER

Hb + meal-matrix

Maize porridge with labelled porcine hemoglobin (57Fe)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Serum ferritin \< 45 µg/L (iron depleted)
* Body weight \< 70 kg
* Body mass index 18,5 - 24,9 kg/m2 (normal weight)

Exclusion Criteria

* Hb \< 120 g/L (anemia)
* CRP \> 5 µg/L (inflammation)
* Strict vegan and vegetarians
* Any metabolic, gastrointestinal kidney or chronic disease
* Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection
* Blood transfusion over the past 6 months
* blood donation over the past 6 months
* Significant blood loss (accident, surgery) over the past 6 months
* Women who are pregnant or breast feeding
* Smoker (\> 1 cigarette per week)
* Continuous/long-term use of medication (except for contraceptives)
* Therapeutic iron infusion over the past 6 months,
* Known hypersensitivity or allergy to iron supplements,
* Intention to become pregnant during the course of the studies,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present studies,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich

OTHER

Sponsor Role lead

Responsible Party

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Nicole Stoffel

Assistantprofessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ETH Zurich, Laboratoy of Clinical Biopharmacy

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Salome Häcki

Role: CONTACT

Phone: +41 44 632 75 78

Email: [email protected]

Facility Contacts

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Salome Häcki, MSc

Role: primary

Other Identifiers

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PHIA

Identifier Type: -

Identifier Source: org_study_id