Iron DeficiencyFe BouillonNCT02327299
Iron Bioavailability From Cubes
A study testing Bouillon fortified with FePP, Bouillon fortified with FePP + Stabilizer and Bouillon fortified with FeSO4 in people with Iron Deficiency, run by Swiss Federal Institute of Technology.
Trial summary
Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Bouillon fortified with FePP, Bouillon fortified with FePP + Stabilizer and Bouillon fortified with FeSO4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 and < 40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With low iron stores (serum ferritin <15µg/L);
- Reported intense sporting activities ≤10h/w;
- Reported alcohol consumption ≤14 units/w;
Show all 9Show fewer
- Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- Willing and able to participate in the study;
- Having given a written informed consent.
Who cannot join
- Being an employee of Unilever or the Laboratory of Human Nutrition of the ETH Zürich;
- Blood donation or significant blood loss over the past 6 months;
- Reported use of any medically- or self-prescribed diet;
- Use of medication (except oral contraceptives)
- Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
- Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
Show all 11Show fewer
- Is pregnant or will be planning pregnancy during the study period;
- Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- Known gastrointestinal or metabolic disorders;
- Moderate or severe anemia defined as Hb < 90 g/L.
- Participation in another clinical trial during the last 30 days prior to the beginning of the study.
About this study
Official title: Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Women
Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron fortification, the addition of iron to regularly consumed foods. In fortification, the chemical nature of the compound to be added plays an important role: depending on the compound sensory qualities of the fortified foods can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to bouillon, as was recently suggested by in vitro experiments in the laboratory.
- Conditions
- Iron Deficiency
- Being tested
- Bouillon fortified with FePP, Bouillon fortified with FePP + Stabilizer, Bouillon fortified with FeSO4, Bouillon fortified with FeSO4 + Stabilizer
- Keywords
- Iron deficiency, Iron fortification
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bouillon fortified with FePPDietary supplement
Bouillon fortified with FePP + StabilizerDietary supplement
Bouillon fortified with FeSO4Dietary supplement
Bouillon fortified with FeSO4 + StabilizerDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| FePP | Experimental | Bouillon fortified with 4mg FePP Receives: Dietary Supplement: Bouillon fortified with FePP |
| FePP + Stabilizer | Experimental | Bouillon fortified with 4mg FePP + Stabilizer Receives: Dietary Supplement: Bouillon fortified with FePP + Stabilizer |
| FeSO4 | Experimental | Bouillon fortified with 4mg FeSO4 Receives: Dietary Supplement: Bouillon fortified with FeSO4 |
| FeSO4 + Stabilizer | Experimental | Bouillon fortified with 4mg FeSO4 + Stabilizer Receives: Dietary Supplement: Bouillon fortified with FeSO4 + Stabilizer |
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 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 posted30 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT02327299
- Sponsor's protocol ID
- FDS-SAV-1615
- Acronym
- Fe Bouillon
- Status last verified
- Dec 2014
- First submitted
- 23 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Women
- ClinicalTrials.gov ID
- NCT02327299
- Acronym / sponsor ID
- Fe Bouillon / FDS-SAV-1615
- Conditions
- Iron Deficiency
- Keywords
- Iron deficiency, Iron fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Dec 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.
Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron fortification, the addition of iron to regularly consumed foods. In fortification, the chemical nature of the compound to be added plays an important role: depending on the compound sensory qualities of the fortified foods can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to bouillon, as was recently suggested by in vitro experiments in the laboratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FePP | Experimental | Dietary Supplement: Bouillon fortified with FePPBouillon fortified with 4mg FePP |
| FePP + Stabilizer | Experimental | Dietary Supplement: Bouillon fortified with FePP + StabilizerBouillon fortified with 4mg FePP + Stabilizer |
| FeSO4 | Experimental | Dietary Supplement: Bouillon fortified with FeSO4Bouillon fortified with 4mg FeSO4 |
| FeSO4 + Stabilizer | Experimental | Dietary Supplement: Bouillon fortified with FeSO4 + StabilizerBouillon fortified with 4mg FeSO4 + Stabilizer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age > 18 and < 40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With low iron stores (serum ferritin <15µg/L);
- Reported intense sporting activities ≤10h/w;
Key exclusion criteria (11 listed)
- Being an employee of Unilever or the Laboratory of Human Nutrition of the ETH Zürich;
- Blood donation or significant blood loss over the past 6 months;
- Reported use of any medically- or self-prescribed diet;
- Use of medication (except oral contraceptives)
- Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
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 |
|---|---|---|
| Bouillon fortified with FePP | Dietary supplement | FePP |
| Bouillon fortified with FePP + Stabilizer | Dietary supplement | FePP + Stabilizer |
| Bouillon fortified with FeSO4 | Dietary supplement | FeSO4 |
| Bouillon fortified with FeSO4 + Stabilizer | Dietary supplement | FeSO4 + Stabilizer |
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 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 30 Dec 2014.
Related trials for Iron Deficiency
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
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.
Questions about this trial
What is this clinical trial studying?
A study testing Bouillon fortified with FePP, Bouillon fortified with FePP + Stabilizer and Bouillon fortified with FeSO4 in people with Iron Deficiency, run by Swiss Federal Institute of Technology.
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 9 inclusion and 11 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 2 primary outcomes in all. 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 30 Dec 2014.