Iron Bioavailability of High Surface Area Ferric Phosphate (HiFe)

September 10, 2021 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhon Pathom
      • Salaya, Nakhon Pathom, Thailand, 73170
        • Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

June 19, 2019

Study Completion (Actual)

July 19, 2019

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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