Iron Bioavailability of High Surface Area Ferric Phosphate

Iron-deficiency Clinical Trial

— HiFe  

Official title:

Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660462
• Other study ID #: HiFe
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: September 2021
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Dietary Supplement:
• FeSO4 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)
• FePO4 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)
• HiFePO4 1 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)
• HiFePO4 2 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)

Locations

Country	Name	City	State
Thailand	Mahidol University	Salaya	Nakhon Pathom

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)