Iron Bioavailability of High Surface Area Ferric Phosphate (HiFe)

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron-deficiency

Treatments: Dietary Supplement: HiFePO4 2 fortified rice test meal; Dietary Supplement: HiFePO4 1 fortified rice test meal; Dietary Supplement: FePO4 fortified rice test meal; Dietary Supplement: FeSO4 fortified rice test meal

Study type: Interventional

Funder types: Other

Identifiers

NCT03660462

HiFe

Details and patient eligibility

About

The primary objective of this study is to compare iron absorption of high surface area ferric phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in non-pregnant women.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women of reproductive age (18 to 49 years) in Thailand
• BMI < 23 kg/m2
• Body weight < 65 kg
• Mildly anaemic to normocythemic (Hb 80-110 g/L)
• Ferritin < 25 µg/L
• Not pregnant (confirmed by pregnancy test stripe) or lactating
• No inflammation (CRP < 5 mg/L)
• Having provided written informed consent

Exclusion criteria

• Haemoglobinopathies (except heterozygosity for haemoglobin E and alpha-thalassemia 1)
• Coeliac disease or other chronic diseases of malabsorption that could influence iron absorption or metabolism
• Blood donation or significant blood loss due to surgery or accident < 4 months before start of the study
• Consumption of vitamin or mineral supplements 2 weeks before start of the study
• Regular use of medication (except oral contraceptives), that influences iron absorption
• Chronic inflammatory disease
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 4 patient groups

FeSO4 fortified rice test meal

Active Comparator group

Treatment:

Dietary Supplement: FeSO4 fortified rice test meal

FePO4 fortified rice test meal

Experimental group

Treatment:

Dietary Supplement: FePO4 fortified rice test meal

HiFePO4 1 fortified rice test meal

Experimental group

Treatment:

Dietary Supplement: HiFePO4 1 fortified rice test meal

HiFePO4 2 fortified rice test meal

Experimental group

Treatment:

Dietary Supplement: HiFePO4 2 fortified rice test meal