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Iron Therapy in Erythropoietic Protoporphyria

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05572125
Collaborator
Alfred Benzon Foundation (Other)
12
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Oral Iron Therapy in Erythropoietic Protoporphyria
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change in erythrocyte protoporphyrin concentration [Before treatment and after 6-8 weeks of treatment]

    Secondary Outcome Measures

    1. Change in hemoglobin and iron parameters [Before treatment and after 6-8 weeks of treatment]

    2. Adverse event [6-8 weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with EPP

    • Taking standard dose of iron tablets due to iron deficiency

    Exclusion Criteria:

    • Pregnant

    • Lactating

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bispebjerg Hospital
    • Alfred Benzon Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ida M. Heerfordt, Principal Investigator, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT05572125
    Other Study ID Numbers:
    • Iron
    First Posted:
    Oct 7, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Protoporphyria, Erythropoietic

    Study Results

    No Results Posted as of Oct 10, 2022