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Iron Bioavailability of High Surface Area Ferric Phosphate

Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660462
Acronym
HiFe
Enrollment
18
Registered
2018-09-06
Start date
2018-11-21
Completion date
2019-07-19
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency

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.

Interventions

DIETARY_SUPPLEMENTFeSO4 fortified rice test meal

Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)

DIETARY_SUPPLEMENTFePO4 fortified rice test meal

Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)

DIETARY_SUPPLEMENTHiFePO4 1 fortified rice test meal

Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)

DIETARY_SUPPLEMENTHiFePO4 2 fortified rice test meal

Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)

Sponsors

Mahidol University
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
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 * Smoking

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorptionMeasured 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).

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026