Iron DeficiencyRice_FeZnNCT02255942
The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
A study testing Ferric Pyrophosphate and Zinc Oxide, Ferrous sulfate and Ferric Pyrophosphate and Zinc Sulfate in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Ferric Pyrophosphate and Zinc Oxide, Ferrous sulfate and Ferric Pyrophosphate and Zinc Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Jul 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Serum Ferritin Level < 15 µg/L
- Body weight <65 kg
- Signed informed consent 4. Body Mass Index in the range of 18.5 to 25
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ETH Zürich, Laboratory of Human Nutrition
Zurich, Canton of Zurich, 8092
About this study
Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.
Read the detailed description
Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.
- Conditions
- Iron Deficiency
- Being tested
- Ferric Pyrophosphate and Zinc Oxide, Ferrous sulfate, Ferric Pyrophosphate and Zinc Sulfate, Ferric Pyrophosphate
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Pyrophosphate and Zinc OxideOther
Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
Ferrous sulfateOther
Rice fortified with Ferrous Sulfate (ZnSO4)
Ferric Pyrophosphate and Zinc SulfateOther
Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
Ferric PyrophosphateOther
Rice fortified with Ferric Pyrophosphate
| Study group | Role | What they receive |
|---|---|---|
| Iron fortified rice | Experimental | Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions. Receives: Other: Ferric Pyrophosphate and Zinc Oxide; Other: Ferrous sulfate; Other: Ferric Pyrophosphate and Zinc Sulfate; Other: Ferric Pyrophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: 2 weeks, 4 weeks
Change from week 4 in the isotopic ratio of iron in blood at week 6
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: 4 weeks, 6 weeks
Secondary outcomes (3)
Haemoglobin
14 or 15 days after each meal administration and at baseline
Measured: baseline, 16th, 30th and 44th day
Plasma Ferritin
14 or 15 days after each meal administration and at baseline
Measured: baseline, 16th, 30th and 44th day
C reactive protein
14 or 15 days after each meal administration and at baseline
Measured: baseline, 16th, 30th and 44th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- PATH
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael Zimmermann, Prof.Dr., MD, Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255942
- Sponsor's protocol ID
- Rice-FePP-Zn
- Acronym
- Rice_FeZn
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hackl L, Zimmermann MB, Zeder C, Parker M, Johns PW, Hurrell RF, Moretti D. Iron Bioavailability from Ferric Pyrophosphate in Extruded Rice Cofortified with Zinc Sulfate Is Greater than When Cofortified with Zinc Oxide in a Human Stable Isotope Study. J Nutr. 2017 Mar;147(3):377-383. doi: 10.3945/jn.116.241778. Epub 2017 Feb 1.
PubMed 28148685
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
- ClinicalTrials.gov ID
- NCT02255942
- Acronym / sponsor ID
- Rice_FeZn / Rice-FePP-Zn
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- PATH
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Oct 2014 (estimated)
- 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.
Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.
Detailed description
Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron fortified rice | Experimental | Other: Ferric Pyrophosphate and Zinc Oxide, Other: Ferrous sulfate, Other: Ferric Pyrophosphate and Zinc Sulfate, Other: Ferric PyrophosphateAdministration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Serum Ferritin Level < 15 µg/L
- Body weight <65 kg
- Signed informed consent 4. Body Mass Index in the range of 18.5 to 25
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ferric Pyrophosphate and Zinc OxideRice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO) | Other | Iron fortified rice |
| Ferrous sulfateRice fortified with Ferrous Sulfate (ZnSO4) | Other | Iron fortified rice |
| Ferric Pyrophosphate and Zinc SulfateRice fortified with Ferric Pyrophosphate and Zinc Sulfate | Other | Iron fortified rice |
| Ferric PyrophosphateRice fortified with Ferric Pyrophosphate | Other | Iron fortified rice |
Primary outcome
Change from baseline in the isotopic ratio of iron in blood at week 2
Time frame: baseline, 2 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 2 in the isotopic ratio of iron in blood at week 4
Time frame: 2 weeks, 4 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 4 in the isotopic ratio of iron in blood at week 6
Time frame: 4 weeks, 6 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
3 secondary outcomes
Haemoglobin
Time frame: baseline, 16th, 30th and 44th day
Plasma Ferritin
Time frame: baseline, 16th, 30th and 44th day
C reactive protein
Time frame: baseline, 16th, 30th and 44th day
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 Apr 2016.
- Derived from this study: PubMed 28148685Hackl L, Zimmermann MB, Zeder C, Parker M, Johns PW, Hurrell RF, Moretti D. Iron Bioavailability from Ferric Pyrophosphate in Extruded Rice Cofortified with Zinc Sulfate Is Greater than When Cofortified with Zinc Oxide in a Human Stable Isotope Study. J Nutr. 2017 Mar;147(3):377-383. doi: 10.3945/jn.116.241778. Epub 2017 Feb 1.
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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.
Michael Zimmermann, Prof.Dr., MD principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric Pyrophosphate and Zinc Oxide, Ferrous sulfate and Ferric Pyrophosphate and Zinc Sulfate in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 4 inclusion and 1 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 Apr 2016. 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 Switzerland. 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?
Change from baseline in the isotopic ratio of iron in blood at week 2 (time frame: baseline, 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255942, which also lists 1 linked publication.
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 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.