NCT07143890

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 12, 2026

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 20, 2025

Last Update Submit

February 11, 2026

Conditions

Iron Deficiency (ID)Iron Absorption

Keywords

Iron sulfateIron fortificationplant-derived heme ironStable isotopesIron bioavailability

Outcome Measures

Primary Outcomes (3)

  • Fractional Iron Absorption (%)

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

    Day 22

  • Fractional Iron Absorption (%)

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

    Day 43

  • Fractional Iron Absorption (%)

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

    Day 64

Secondary Outcomes (19)

  • Hemoglobin (g/dL)

    Day 1

  • Hemoglobin (g/dL)

    Day 22

  • Hemoglobin (g/dL)

    Day 43

  • Hemoglobin (g/dL)

    Day 64

  • Serum Ferritin (µg/L)

    Day 1

  • +14 more secondary outcomes

Study Arms (8)

Iron chlorophyllin + Water

EXPERIMENTAL

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

Other: Iron chlorophyllin + no-matrix

Soy hemoglobin + Water

EXPERIMENTAL

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

Other: SoyHb + no-matrix

Ferrous sulfate + Water (negative control)

ACTIVE COMPARATOR

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

Other: FeSO4 + no-matrix

Porcine hemoglobin + Water (positive control)

ACTIVE COMPARATOR

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

Other: Hb + no-matrix

Iron Chlorophyllin + Inhibitory Meal

EXPERIMENTAL

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

Other: Iron chlorophyllin + meal-matrix

Soy Hemoglobin + Inhibitory Meal

EXPERIMENTAL

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

Other: SoyHb + meal-matrix

Ferrous sulfate + Inhibitory Meal (negative control)

ACTIVE COMPARATOR

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

Other: FeSO4 + meal-matrix

Porcine hemoglobin + Inhibitory Meal (positive control)

ACTIVE COMPARATOR

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

Other: Hb + meal-matrix

Interventions

SoyHb + no-matrixOTHER

Water with labelled soy hemoglobin (58Fe)

Soy hemoglobin + Water
FeSO4 + no-matrixOTHER

Water with labelled ferrous sulfate (58Fe)

Ferrous sulfate + Water (negative control)
Iron chlorophyllin + meal-matrixOTHER

Maize porridge with labelled Fe chlorophyllin (54Fe)

Iron Chlorophyllin + Inhibitory Meal
SoyHb + meal-matrixOTHER

Maize porridge with labelled soy hemoglobin (58Fe)

Soy Hemoglobin + Inhibitory Meal
FeSO4 + meal-matrixOTHER

Maize porridge with labelled ferrous sulfate (57Fe)

Ferrous sulfate + Inhibitory Meal (negative control)
Hb + meal-matrixOTHER

Maize porridge with labelled porcine hemoglobin (57Fe)

Porcine hemoglobin + Inhibitory Meal (positive control)
Iron chlorophyllin + no-matrixOTHER

Water with labelled Fe chlorophyllin (54Fe)

Iron chlorophyllin + Water
Hb + no-matrixOTHER

Water with labelled porcine hemoglobin (57Fe)

Porcine hemoglobin + Water (positive control)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zurich, Laboratoy of Clinical Biopharmacy

Zurich, 8092, Switzerland

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Salome Häcki

CONTACT

+41 44 632 75 78phiastudy@pharma.ethz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistantprofessor

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 27, 2025

Study Start

September 22, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 12, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)