Iron DeficiencyNCT02176759
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
A study testing Administration of rice fortified with regular FePP, Administration of rice fortified with regular FePP with citrate added during extrusion and Administration of rice fortified with regular FePP and citrate added at consumption in people with Iron Deficiency and Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. 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, Anemia, Iron Deficiency Anemia
- What is being tested?
- Administration of rice fortified with regular FePP, Administration of rice fortified with regular FePP with citrate added during extrusion and Administration of rice fortified with regular FePP and citrate added at consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Dec 2014
- 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, 18 to 45 years old
- Normal body Mass Index (18.5 - 25 kg/m2)
- Body weight < 65 kg
- Signed informed consent
Who cannot join
- Pregnancy (assessed by a pregnancy test)
- Lactating
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
- Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Human Nutrition Laboratory
Zurich, Canton of Zurich, 8092
About this study
Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP need to be investigated. The primary objectives of the present study are: 1) to test whether the presence of citrate in iron fortified rice with FePP results in higher iron bioavailability, and 2) to test whether the presence of citrate in the rice grain during the extrusion and cooking process results in higher iron bioavailability compared with iron-fortified rice where citrate has been added shortly before consumption. As a secondary objective the investigators will compare the absorption from different FePP combinations with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the addition of citrate enhances iron absorption and that the positive effect is greater when the citrate is added during the extrusion.
The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2) regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at the time of consumption. Iron absorption will be measured as erythrocyte incorporation of stable iron isotopes at least 14 days after the administration of the isotopically labelled test meals. The iron absorption from the different meals within the same participant will be compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.
The present study will provide important data where iron bioavailability from rice is accurately and directly measured using stable isotopic labels as absorption tracers. This direct data can be used to base decisions on the level of fortification, can potentially reduce costs and optimize iron delivery to the targeted population in iron fortification programs.
- Conditions
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- Being tested
- Administration of rice fortified with regular FePP, Administration of rice fortified with regular FePP with citrate added during extrusion, Administration of rice fortified with regular FePP and citrate added at consumption, Administration of rice fortified with ferrous sulphate
- Medical subject headings
- Iron Deficiencies, Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of rice fortified with regular FePPOther
Administration of rice fortified with regular FePP with citrate added during extrusionOther
Administration of rice fortified with regular FePP and citrate added at consumptionOther
Administration of rice fortified with ferrous sulphateOther
| Study group | Role | What they receive |
|---|---|---|
| Regular FePP | Experimental | Rice (50g dry weight) fortified with 4mg regular FePP Receives: Other: Administration of rice fortified with regular FePP |
| Regular FePP with citrate added during extrusion | Experimental | Rice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process Receives: Other: Administration of rice fortified with regular FePP with citrate added during extrusion |
| Regular FePP with citrated added at consumption | Experimental | Rice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption Receives: Other: Administration of rice fortified with regular FePP and citrate added at consumption |
| Ferrous sulphate | Active comparator | Rice (50g dry weight) fortified with 4mg ferrous sulphate Receives: Other: Administration of rice fortified with ferrous sulphate |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176759
- Sponsor's protocol ID
- Rice_SFePP
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
Publications
Hackl L, Speich C, Zeder C, Sanchez-Ferrer A, Adelmann H, de Pee S, Tay F, Zimmermann MB, Moretti D. Cold Extrusion but Not Coating Affects Iron Bioavailability from Fortified Rice in Young Women and Is Associated with Modifications in Starch Microstructure and Mineral Retention during Cooking. J Nutr. 2017 Dec;147(12):2319-2325. doi: 10.3945/jn.117.259085. Epub 2017 Oct 18.
PubMed 29046406Hackl L, Cercamondi CI, Zeder C, Wild D, Adelmann H, Zimmermann MB, Moretti D. Cofortification of ferric pyrophosphate and citric acid/trisodium citrate into extruded rice grains doubles iron bioavailability through in situ generation of soluble ferric pyrophosphate citrate complexes. Am J Clin Nutr. 2016 May;103(5):1252-9. doi: 10.3945/ajcn.115.128173. Epub 2016 Apr 6.
PubMed 27053382
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Rice Fortified With Ferric Pyrophosphate
- ClinicalTrials.gov ID
- NCT02176759
- Acronym / sponsor ID
- Rice_SFePP
- Conditions
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 27 Jun 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.
Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP need to be investigated. The primary objectives of the present study are: 1) to test whether the presence of citrate in iron fortified rice with FePP results in higher iron bioavailability, and 2) to test whether the presence of citrate in the rice grain during the extrusion and cooking process results in higher iron bioavailability compared with iron-fortified rice where citrate has been added shortly before consumption. As a secondary objective the investigators will compare the absorption from different FePP combinations with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the addition of citrate enhances iron absorption and that the positive effect is greater when the citrate is added during the extrusion.
The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2) regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at the time of consumption. Iron absorption will be measured as erythrocyte incorporation of stable iron isotopes at least 14 days after the administration of the isotopically labelled test meals. The iron absorption from the different meals within the same participant will be compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.
The present study will provide important data where iron bioavailability from rice is accurately and directly measured using stable isotopic labels as absorption tracers. This direct data can be used to base decisions on the level of fortification, can potentially reduce costs and optimize iron delivery to the targeted population in iron fortification programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regular FePP | Experimental | Other: Administration of rice fortified with regular FePPRice (50g dry weight) fortified with 4mg regular FePP |
| Regular FePP with citrate added during extrusion | Experimental | Other: Administration of rice fortified with regular FePP with citrate added during extrusionRice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process |
| Regular FePP with citrated added at consumption | Experimental | Other: Administration of rice fortified with regular FePP and citrate added at consumptionRice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption |
| Ferrous sulphate | Active comparator | Other: Administration of rice fortified with ferrous sulphateRice (50g dry weight) fortified with 4mg ferrous sulphate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, 18 to 45 years old
- Normal body Mass Index (18.5 - 25 kg/m2)
- Body weight < 65 kg
- Signed informed consent
Key exclusion criteria (8 listed)
- Pregnancy (assessed by a pregnancy test)
- Lactating
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
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 |
|---|---|---|
| Administration of rice fortified with regular FePP | Other | Regular FePP |
| Administration of rice fortified with regular FePP with citrate added during extrusion | Other | Regular FePP with citrate added during extrusion |
| Administration of rice fortified with regular FePP and citrate added at consumption | Other | Regular FePP with citrated added at consumption |
| Administration of rice fortified with ferrous sulphate | Other | Ferrous sulphate |
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.
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 24 Dec 2014.
- Derived from this study: PubMed 29046406Hackl L, Speich C, Zeder C, Sanchez-Ferrer A, Adelmann H, de Pee S, Tay F, Zimmermann MB, Moretti D. Cold Extrusion but Not Coating Affects Iron Bioavailability from Fortified Rice in Young Women and Is Associated with Modifications in Starch Microstructure and Mineral Retention during Cooking. J Nutr. 2017 Dec;147(12):2319-2325. doi: 10.3945/jn.117.259085. Epub 2017 Oct 18.
- Derived from this study: PubMed 27053382Hackl L, Cercamondi CI, Zeder C, Wild D, Adelmann H, Zimmermann MB, Moretti D. Cofortification of ferric pyrophosphate and citric acid/trisodium citrate into extruded rice grains doubles iron bioavailability through in situ generation of soluble ferric pyrophosphate citrate complexes. Am J Clin Nutr. 2016 May;103(5):1252-9. doi: 10.3945/ajcn.115.128173. Epub 2016 Apr 6.
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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 Administration of rice fortified with regular FePP, Administration of rice fortified with regular FePP with citrate added during extrusion and Administration of rice fortified with regular FePP and citrate added at consumption in people with Iron Deficiency and Anemia, 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 8 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 24 Dec 2014. 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 NCT02176759, which also lists 2 linked publications.
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 24 Dec 2014.