Iron Bioavailability of High Surface Area Ferric Phosphate

Study Overview
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Brief Summary
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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.

Official Title
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Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

Conditions
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Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: FeSO4 fortified rice test meal
* Dietary Supplement: FePO4 fortified rice test meal
* Dietary Supplement: HiFePO4 1 fortified rice test meal
* Dietary Supplement: HiFePO4 2 fortified rice test meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FeSO4 fortified rice test meal<br> | Dietary Supplement: FeSO4 fortified rice test meal<br>* Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)<br>|
| Experimental: FePO4 fortified rice test meal<br> | Dietary Supplement: FePO4 fortified rice test meal<br>* Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)<br>|
| Experimental: HiFePO4 1 fortified rice test meal<br> | Dietary Supplement: HiFePO4 1 fortified rice test meal<br>* Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)<br>|
| Experimental: HiFePO4 2 fortified rice test meal<br> | Dietary Supplement: HiFePO4 2 fortified rice test meal<br>* Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional iron absorption | 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). | Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31) |