Iron Deficiency AnemiaNCT03623997
Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women
An observational study of Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. 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
- What is being tested?
- Iron stable isotope labeled iron(II) sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2017to 30 Jun 2018
- Phase
- Observational
- 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
Study population: Young women with iron-deficiency anemia
Who may be able to join
- Ferritin <15 µg/L
- Hb 8-11.9 g/dl
- BMI 18.5-24.9 kg/m2
- Body weight <70 kg
Who cannot join
- Severe anemia (Hb <8 g/dl)
- Elevated CRP >5.0 mg/L
- Chronic disease
- Long-term medication, except contraception
- Consumption of Mineral and Vitamin supplements within the study period
- Therapeutic iron infusion over the past 6 months
- Pregnancy or breastfeeding
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia
Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron stable isotope labeled iron(II) sulfate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron stable isotope labeled iron(II) sulfateOther
Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia
| Study group | Role | What they receive |
|---|---|---|
| Stable isotope labeled iron II sulfate | All subjects will go through two iron absorption study cycles. In one cycle they get 100mg oral iron labeled with stable isotopes on two consecutive and on one alternate day and in another cycle they get 200mg oral iron labeled with stable isotopes on two consecutive and on one alternate day. Half of the subjects start with the 100mg cycle whereas the other half starts with the 200mg cycle. Receives: Other: Iron stable isotope labeled iron(II) sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional and total iron absorption
Fractional and total iron absorption from different supplementation regimens
Measured: absorption will be measured 14days after the 100mg and 200mg cycle
Serum hepcidin
Serum hepcidin after the administration of different doses and using different regimens
Measured: right before the administration of an iron dose
Serum EPO
Serum EPO after the administration of different doses and using different
Measured: right before the administration of an iron dose
Secondary outcomes (6)
Serum ferritin
Determination of iron status
Measured: right before the administration of an iron dose
Serum TfR
Determination of iron status
Measured: right before the administration of an iron dose
Serum CRP
Determination of inflammation status
Measured: right before the administration of an iron dose
Serum AGP
Determination of inflammation status
Measured: right before the administration of an iron dose
Serum iron
Determination of iron status
Measured: right before the administration of an iron dose
Total iron binding capacity
Determination of iron status
Measured: right before the administration of an iron dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start10 Oct 2017
- Primary completion8 Jan 2018
- Study completion30 Jun 2018
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 Deficiency AnemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623997
- Sponsor's protocol ID
- FeSupp_Anemia
- Status last verified
- Aug 2018
- First submitted
- 6 Nov 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
PubMed 31413088
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT03623997
- Acronym / sponsor ID
- FeSupp_Anemia
- Conditions
- Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable isotope labeled iron II sulfate | – | Other: Iron stable isotope labeled iron(II) sulfateAll subjects will go through two iron absorption study cycles. In one cycle they get 100mg oral iron labeled with stable isotopes on two consecutive and on one alternate day and in another cycle they get 200mg oral iron labeled with stable isotopes on two consecutive and on one alternate day. Half of the subjects start with the 100mg cycle whereas the other half starts with the 200mg cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young women with iron-deficiency anemia
Key inclusion criteria (4 listed)
- Ferritin <15 µg/L
- Hb 8-11.9 g/dl
- BMI 18.5-24.9 kg/m2
- Body weight <70 kg
Key exclusion criteria (8 listed)
- Severe anemia (Hb <8 g/dl)
- Elevated CRP >5.0 mg/L
- Chronic disease
- Long-term medication, except contraception
- Consumption of Mineral and Vitamin supplements within the study period
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 |
|---|---|---|
| Iron stable isotope labeled iron(II) sulfateAdministration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia | Other | Stable isotope labeled iron II sulfate |
Primary outcome
Fractional and total iron absorption
Time frame: absorption will be measured 14days after the 100mg and 200mg cycle
Fractional and total iron absorption from different supplementation regimens
Serum hepcidin
Time frame: right before the administration of an iron dose
Serum hepcidin after the administration of different doses and using different regimens
Serum EPO
Time frame: right before the administration of an iron dose
Serum EPO after the administration of different doses and using different
6 secondary outcomes
Serum ferritin
Time frame: right before the administration of an iron dose
Serum TfR
Time frame: right before the administration of an iron dose
Serum CRP
Time frame: right before the administration of an iron dose
Serum AGP
Time frame: right before the administration of an iron dose
Serum iron
Time frame: right before the administration of an iron dose
Total iron binding capacity
Time frame: right before the administration of an iron dose
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 22 Aug 2018.
- Derived from this study: PubMed 31413088Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
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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?
An observational study of Iron Deficiency 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 22 Aug 2018. 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?
Fractional and total iron absorption (time frame: absorption will be measured 14days after the 100mg and 200mg cycle). 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 NCT03623997, 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 22 Aug 2018.