Erythropoietic ProtoporphyriaNCT05572125
Iron Therapy in Erythropoietic Protoporphyria
An observational study of Erythropoietic Protoporphyria and Iron-deficiency, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Erythropoietic Protoporphyria, Iron-deficiency
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Oct 2022to 14 Feb 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with EPP taking oral iron tablets due to iron deficiency
Who may be able to join
- Diagnosed with EPP
- Taking standard dose of iron tablets due to iron deficiency
Who cannot join
- Pregnant
- Lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Iron Therapy in Erythropoietic Protoporphyria
Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.
- Conditions
- Erythropoietic Protoporphyria, Iron-deficiency
- Medical subject headings
- Protoporphyria, Erythropoietic, Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythrocyte protoporphyrin concentration
Measured: Before treatment and after 6-8 weeks of treatment
Secondary outcomes (2)
Change in hemoglobin and iron parameters
Measured: Before treatment and after 6-8 weeks of treatment
Adverse event
Measured: 6-8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start17 Oct 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythropoietic ProtoporphyriaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred Benzon Foundation
- Responsible party
- Principal investigator, Ida M. Heerfordt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572125
- Sponsor's protocol ID
- Iron
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iron Therapy in Erythropoietic Protoporphyria
- ClinicalTrials.gov ID
- NCT05572125
- Acronym / sponsor ID
- Iron
- Conditions
- Erythropoietic Protoporphyria, Iron-deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Alfred Benzon Foundation
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 7 Oct 2022 (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.
Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with EPP taking oral iron tablets due to iron deficiency
Key inclusion criteria (2 listed)
- Diagnosed with EPP
- Taking standard dose of iron tablets due to iron deficiency
Key exclusion criteria (2 listed)
- Pregnant
- Lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in erythrocyte protoporphyrin concentration
Time frame: Before treatment and after 6-8 weeks of treatment
2 secondary outcomes
Change in hemoglobin and iron parameters
Time frame: Before treatment and after 6-8 weeks of treatment
Adverse event
Time frame: 6-8 weeks of treatment
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 23 Feb 2023.
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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 Erythropoietic Protoporphyria and Iron-deficiency, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 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 23 Feb 2023. 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 Denmark. 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 in erythrocyte protoporphyrin concentration (time frame: Before treatment and after 6-8 weeks of treatment). 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 23 Feb 2023.