Iron-deficiencyHiFeNCT03660462
Iron Bioavailability of High Surface Area Ferric Phosphate
A study testing FeSO4 fortified rice test meal, FePO4 fortified rice test meal and HiFePO4 1 fortified rice test meal in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- FeSO4 fortified rice test meal, FePO4 fortified rice test meal and HiFePO4 1 fortified rice test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- 21 Nov 2018to 19 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Iron-deficiency
- Being tested
- FeSO4 fortified rice test meal, FePO4 fortified rice test meal, HiFePO4 1 fortified rice test meal, HiFePO4 2 fortified rice test meal
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeSO4 fortified rice test mealDietary supplement
Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)
FePO4 fortified rice test mealDietary supplement
Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)
HiFePO4 1 fortified rice test mealDietary supplement
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)
HiFePO4 2 fortified rice test mealDietary supplement
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)
| Study group | Role | What they receive |
|---|---|---|
| FeSO4 fortified rice test meal | Active comparator | Not described Receives: Dietary Supplement: FeSO4 fortified rice test meal |
| FePO4 fortified rice test meal | Experimental | Not described Receives: Dietary Supplement: FePO4 fortified rice test meal |
| HiFePO4 1 fortified rice test meal | Experimental | Not described Receives: Dietary Supplement: HiFePO4 1 fortified rice test meal |
| HiFePO4 2 fortified rice test meal | Experimental | Not described Receives: Dietary Supplement: HiFePO4 2 fortified rice test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start21 Nov 2018
- Primary completion19 Jun 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660462
- Sponsor's protocol ID
- HiFe
- Acronym
- HiFe
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women
- ClinicalTrials.gov ID
- NCT03660462
- Acronym / sponsor ID
- HiFe / HiFe
- Conditions
- Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FeSO4 fortified rice test meal | Active comparator | Dietary Supplement: FeSO4 fortified rice test meal |
| FePO4 fortified rice test meal | Experimental | Dietary Supplement: FePO4 fortified rice test meal |
| HiFePO4 1 fortified rice test meal | Experimental | Dietary Supplement: HiFePO4 1 fortified rice test meal |
| HiFePO4 2 fortified rice test meal | Experimental | Dietary Supplement: HiFePO4 2 fortified rice test meal |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeSO4 fortified rice test mealRice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4) | Dietary supplement | FeSO4 fortified rice test meal |
| FePO4 fortified rice test mealRice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4) | Dietary supplement | FePO4 fortified rice test meal |
| HiFePO4 1 fortified rice test mealRice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4) | Dietary supplement | HiFePO4 1 fortified rice test meal |
| HiFePO4 2 fortified rice test mealRice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4) | Dietary supplement | HiFePO4 2 fortified rice test meal |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeSO4 fortified rice test meal, FePO4 fortified rice test meal and HiFePO4 1 fortified rice test meal in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (time frame: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.