Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Fractional iron absorption
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
FeSO4 fortified rice test meal
Intervention: FeSO4 fortified rice test meal (Dietary Supplement)
FePO4 fortified rice test meal
Intervention: FePO4 fortified rice test meal (Dietary Supplement)
HiFePO4 1 fortified rice test meal
Intervention: HiFePO4 1 fortified rice test meal (Dietary Supplement)
HiFePO4 2 fortified rice test meal
Intervention: HiFePO4 2 fortified rice test meal (Dietary Supplement)
Outcomes
Primary Outcomes
Fractional iron absorption
Time Frame: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)
Iron absorption will be determined by measurement of the isotopic ratio change from the 4 different types of iron vehicles (FeSO4 fortified rice test meal, FePO4 fortified rice test meal, HiFePO4 1 fortified rice test meal, HiFePO4 2 fortified rice test meal).
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Michael B. Zimmermann
Prof. Dr. med.
Swiss Federal Institute of Technology