Iron Bioavailability of High Surface Area Ferric Phosphate

Not Applicable

Completed

• Conditions: Iron-deficiency
• Interventions: Dietary Supplement: FePO4 fortified rice test meal; Dietary Supplement: HiFePO4 2 fortified rice test meal; Dietary Supplement: FeSO4 fortified rice test meal; Dietary Supplement: HiFePO4 1 fortified rice test meal

• Registration Number: NCT03660462
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2018-11-21
• Primary Completion: 2019-06-19
• Study Completion: 2019-07-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FePO4 fortified rice test meal	FePO4 fortified rice test meal	-
HiFePO4 2 fortified rice test meal	HiFePO4 2 fortified rice test meal	-
FeSO4 fortified rice test meal	FeSO4 fortified rice test meal	-
HiFePO4 1 fortified rice test meal	HiFePO4 1 fortified rice test meal	-

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption	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).

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Salaya, Nakhon Pathom, Thailand