NCT05572125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

October 5, 2022

Last Update Submit

February 22, 2023

Conditions

Erythropoietic ProtoporphyriaIron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in erythrocyte protoporphyrin concentration

    Before treatment and after 6-8 weeks of treatment

Secondary Outcomes (2)

  • Change in hemoglobin and iron parameters

    Before treatment and after 6-8 weeks of treatment

  • Adverse event

    6-8 weeks of treatment

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with EPP taking oral iron tablets due to iron deficiency

You may qualify if:

  • Diagnosed with EPP
  • Taking standard dose of iron tablets due to iron deficiency

You may not qualify if:

  • Pregnant
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Protoporphyria, ErythropoieticAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Porphyrias, HepaticLiver DiseasesDigestive System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPorphyriasMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

October 17, 2022

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

DK(1)