Iron DeficiencyNCT02050932
The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans
A study testing 60 mg Fe as FeSO4 with stable isotopic labels in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. 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?
- 60 mg Fe as FeSO4 with stable isotopic labels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Dec 2013
- 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
- Generally healthy, no blood donation in the last 4 months, not pregnant, not lactating, not taking vitamin and mineral supplements 2 weeks prior the study, non smoker, weight <65 Kg, BMI between 18 and 25.
- No anemia (defined as 11.7 g/dl, Serum ferritin level < 20 microgram/L).
Who cannot join
None listed.
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
Official title: The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans: Effect of the Time of Administration and Consecutive Day Administration of Commonly Used Dosages
Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: In a recent study conducted in our laboratory it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens.
Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron supplement dosages given at different times of the day (Study 2).
Read more
Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic subjects will be excluded from the study. Thirty two subjects will be included with serum ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1 (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be collected to monitor sHep and iron status markers.
Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens.
- Conditions
- Iron Deficiency
- Being tested
- 60 mg Fe as FeSO4 with stable isotopic labels
- Keywords
- hepcidin, iron bioavailability, iron supplementation
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 mg Fe as FeSO4 with stable isotopic labelsDietary supplement
Subjects will receive FeSo4 supplements labeled with stable isotopic labels (54Fe, 57Fe, 58Fe) and iron absorption will be measured for each administration
| Study group | Role | What they receive |
|---|---|---|
| Iron absorption assessement | Experimental | 60 mg Fe as FeSO4 with stable isotopic labels participants will receive at different times of the day (total of three dosages) and follow a standardized diet scheme.
Subjects will act as their own controls during the study Receives: Dietary Supplement: 60 mg Fe as FeSO4 with stable isotopic labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption of stable isotopic tracers.
Stable iron isotopes will be administered under standardized conditions and close supervision. Iron absorption will be calculated from the shift in the normal isotopic abundance in Red blood cells 14 days after test meal incorporation.
Measured: 14 days
Secondary outcomes (3)
Iron status
To characterize participants, iron status will be assessed by measuring serum ferritin.
Measured: 14 days
Inflammatory status
To characterize subjects participating to the study, C- reactive protein will be measured as inflammatory marker.
Measured: 14 days
Hepcidin level
As a determinant of iron absorption (primary outcome) hepcidin level will be measured at all timepoint prior administration of stable isotopic label tracers.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Moretti, PhD, Principal investigator, ETH Zürich, Laboratory of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050932
- Sponsor's protocol ID
- EK 2013-N-41
- Status last verified
- Jan 2014
- First submitted
- 8 Nov 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
PubMed 26289639
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans: Effect of the Time of Administration and Consecutive Day Administration of Commonly Used Dosages
- ClinicalTrials.gov ID
- NCT02050932
- Acronym / sponsor ID
- EK 2013-N-41
- Conditions
- Iron Deficiency
- Keywords
- hepcidin, iron bioavailability, iron supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 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.
Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: In a recent study conducted in our laboratory it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens.
Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron supplement dosages given at different times of the day (Study 2).
Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic subjects will be excluded from the study. Thirty two subjects will be included with serum ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1 (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be collected to monitor sHep and iron status markers.
Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron absorption assessement | Experimental | Dietary Supplement: 60 mg Fe as FeSO4 with stable isotopic labels60 mg Fe as FeSO4 with stable isotopic labels participants will receive at different times of the day (total of three dosages) and follow a standardized diet scheme. Subjects will act as their own controls during the study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally healthy, no blood donation in the last 4 months, not pregnant, not lactating, not taking vitamin and mineral supplements 2 weeks prior the study, non smoker, weight <65 Kg, BMI between 18 and 25.
- No anemia (defined as 11.7 g/dl, Serum ferritin level < 20 microgram/L).
Key exclusion criteria (0 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 |
|---|---|---|
| 60 mg Fe as FeSO4 with stable isotopic labelsSubjects will receive FeSo4 supplements labeled with stable isotopic labels (54Fe, 57Fe, 58Fe) and iron absorption will be measured for each administration | Dietary supplement | Iron absorption assessement |
Primary outcome
Iron absorption of stable isotopic tracers.
Time frame: 14 days
Stable iron isotopes will be administered under standardized conditions and close supervision. Iron absorption will be calculated from the shift in the normal isotopic abundance in Red blood cells 14 days after test meal incorporation.
3 secondary outcomes
Iron status
Time frame: 14 days
Inflammatory status
Time frame: 14 days
Hepcidin level
Time frame: 14 days
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 31 Jan 2014.
- Derived from this study: PubMed 26289639Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
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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 Zürich, Laboratory of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60 mg Fe as FeSO4 with stable isotopic labels 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 2 inclusion and 0 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 31 Jan 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?
Iron absorption of stable isotopic tracers. (time frame: 14 days). 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 NCT02050932, 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 31 Jan 2014.