Iron BioavailabilityNCT02993835
Iron Bioavailability From Fortified Food
A study testing Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58 in people with Iron Bioavailability, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds. 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 Bioavailability
- What is being tested?
- Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2016to Apr 2017
- 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
- Women aged 18-40 years old
- Healthy, based on the medical screening visit including a blood formula
- Normal BMI for age (18.5-25.0 kg/m2)
- Weight less than 65 kg
- Able to understand and to sign written informed consent prior to trial entry
- Informed consent signed
Who cannot join
- Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
- Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
- Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
- Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
- Diagnosed food allergy.
Show all 18Show fewer
- Pregnancy (tested in plasma at screening) and/or lactation.
- History of cancer within the past year.
- Significant weight loss during the last 3 months (10% and more)
- Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
- Iron supplementation therapy or perfusion in the last three months.
- Smokers (> 5 cigarettes per day).
- Have a high alcohol consumption (more than 2 drinks/day).
- Consumption of illicit drugs (anamnesis only).
- Subject having a hierarchical link with the investigator or co-investigators.
- Subject who cannot be expected to comply with treatment or study procedure.
- Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
- Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Bioavailability From Fortified Food in Healthy Women
Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds.
Read the detailed description
This single center trial will be single-blind to the subject, controlled, fully randomized with crossover design in 22 healthy females aged 18-40 years old.
Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after last stable isotope intake blood sampling (V7).
- Conditions
- Iron Bioavailability
- Being tested
- Labeled iron salt Fe54, Labeled iron salt Fe57, Labeled iron salt Fe58
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labeled iron salt Fe54Other
Fe salt enriched with Fe 54 isotopes
Labeled iron salt Fe57Other
Fe salt enriched with Fe 57 isotopes
Labeled iron salt Fe58Other
Fe salt enriched with Fe 58 isotopes
| Study group | Role | What they receive |
|---|---|---|
| Labeled iron salt (Fe54) | Active comparator | Labeled iron salt (Fe54) with bouillon Receives: Other: Labeled iron salt Fe54 |
| Labeled iron salt (Fe57) | Active comparator | Labeled iron salt (Fe57) with bouillon Receives: Other: Labeled iron salt Fe57 |
| Labeled iron salt (Fe58) | Experimental | Labeled iron salt (Fe58) with bouillon Receives: Other: Labeled iron salt Fe58 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation.
FIA will be calculated based on the measured shift of iron isotope ratios in the blood 14 days after the test meal administrations. The amounts of 57Fe, 54Fe and 58Fe in the blood will be calculated on the principle of isotope dilution by considering that iron isotopic labels are not mono-isotopic (Walczyk et al., 1997; Cercamondi, 2013). Circulating iron will be calculated based on blood volume and hemoglobin concentration (Kastenmayer et al., 1994). Blood volume will be indirectly measured based on height and weight and calculated using the formula proposed by Brown et al (1962). For calculations of fractional absorption, 80% incorporation of the absorbed iron into red blood cells is assumed.
Measured: 14 days after last stable isotope adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron BioavailabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Moretti, PhD, Principal investigator, ETH Zurich, Human Nutrition Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993835
- Sponsor's protocol ID
- 16.15.NRC
- Status last verified
- May 2017
- First submitted
- 7 Dec 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability From Fortified Food in Healthy Women
- ClinicalTrials.gov ID
- NCT02993835
- Acronym / sponsor ID
- 16.15.NRC
- Conditions
- Iron Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Dec 2016 (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.
Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds.
Detailed description
This single center trial will be single-blind to the subject, controlled, fully randomized with crossover design in 22 healthy females aged 18-40 years old.
Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after last stable isotope intake blood sampling (V7).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Labeled iron salt (Fe54) | Active comparator | Other: Labeled iron salt Fe54Labeled iron salt (Fe54) with bouillon |
| Labeled iron salt (Fe57) | Active comparator | Other: Labeled iron salt Fe57Labeled iron salt (Fe57) with bouillon |
| Labeled iron salt (Fe58) | Experimental | Other: Labeled iron salt Fe58Labeled iron salt (Fe58) with bouillon |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-40 years old
- Healthy, based on the medical screening visit including a blood formula
- Normal BMI for age (18.5-25.0 kg/m2)
- Weight less than 65 kg
- Able to understand and to sign written informed consent prior to trial entry
Key exclusion criteria (18 listed)
- Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
- Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
- Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
- Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
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 |
|---|---|---|
| Labeled iron salt Fe54Fe salt enriched with Fe 54 isotopes | Other | Labeled iron salt (Fe54) |
| Labeled iron salt Fe57Fe salt enriched with Fe 57 isotopes | Other | Labeled iron salt (Fe57) |
| Labeled iron salt Fe58Fe salt enriched with Fe 58 isotopes | Other | Labeled iron salt (Fe58) |
Primary outcome
Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation.
Time frame: 14 days after last stable isotope adminstration
FIA will be calculated based on the measured shift of iron isotope ratios in the blood 14 days after the test meal administrations. The amounts of 57Fe, 54Fe and 58Fe in the blood will be calculated on the principle of isotope dilution by considering that iron isotopic labels are not mono-isotopic (Walczyk et al., 1997; Cercamondi, 2013). Circulating iron will be calculated based on blood volume and hemoglobin concentration (Kastenmayer et al., 1994). Blood volume will be indirectly measured based on height and weight and calculated using the formula proposed by Brown et al (1962). For calculations of fractional absorption, 80% incorporation of the absorbed iron into red blood cells is assumed.
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 16 May 2017.
- 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.
Diego Moretti, PhD principal investigator
ETH Zurich, Human Nutrition Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labeled iron salt Fe54, Labeled iron salt Fe57 and Labeled iron salt Fe58 in people with Iron Bioavailability, run by Société des Produits Nestlé (SPN) 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 6 inclusion and 18 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 16 May 2017. 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?
Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation. (time frame: 14 days after last stable isotope adminstration). 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 16 May 2017.