Iron Absorption From Plant Heme Iron (PHIA)

ETH Zurich

Status: Enrolling

Conditions: Iron Absorption; Iron Deficiency (ID)

Treatments: Other: Iron chlorophyllin + no-matrix; Other: Hb + no-matrix; Other: FeSO4 + meal-matrix; Other: Hb + meal-matrix; Other: Iron chlorophyllin + meal-matrix; Other: FeSO4 + no-matrix; Other: SoyHb + meal-matrix; Other: SoyHb + no-matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT07143890

PHIA

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 8 patient groups

Iron chlorophyllin + Water

Experimental group

Description:

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

Treatment:

Other: Iron chlorophyllin + no-matrix

Soy hemoglobin + Water

Experimental group

Description:

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

Treatment:

Other: SoyHb + no-matrix

Ferrous sulfate + Water (negative control)

Active Comparator group

Description:

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

Treatment:

Other: FeSO4 + no-matrix

Porcine hemoglobin + Water (positive control)

Active Comparator group

Description:

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

Treatment:

Other: Hb + no-matrix

Iron Chlorophyllin + Inhibitory Meal

Experimental group

Description:

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

Treatment:

Other: Iron chlorophyllin + meal-matrix

Soy Hemoglobin + Inhibitory Meal

Experimental group

Description:

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

Treatment:

Other: SoyHb + meal-matrix

Ferrous sulfate + Inhibitory Meal (negative control)

Active Comparator group

Description:

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

Treatment:

Other: FeSO4 + meal-matrix

Porcine hemoglobin + Inhibitory Meal (positive control)

Active Comparator group

Description:

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

Treatment:

Other: Hb + meal-matrix