Oral Iron for Erythropoietic Protoporphyrias
Completed · Not applicable
Conditions studied: Erythropoietic Protoporphyria, EPP, X-linked Protoporphyria, XLP
In brief
In the medical literature there are conflicting reports on whether iron improves symptoms in patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of this study is to determine the effect of oral iron for EPP and XLP patients.
Key facts
- Study ID
- NCT02979249
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 16
- Starts
- 2016-12-01
- Expected to finish
- 2019-07-19
- Last updated by the study team
- 2020-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrollment in the Longitudinal Study of the Porphyrias
- Male or female age ≥18 years
- History of nonblistering cutaneous photosensitivity
- Biochemical findings - A marked increase in erythrocyte protoporphyrin (total erythrocyte protoporphyrin >400 ug/dL) with a predominance of metal-free protoporphyrin
- Serum ferritin ≤30 ng/mL at baseline
- Able to tolerate oral iron
You may not qualify if…
- History of liver or bone marrow transplant or clinically significant liver dysfunction as determined by the investigator
- Known or suspected allergy to oral iron based on patient report
- Clinical evidence of active and ongoing GI bleeding
- Use of any other clinical or experimental therapy in the past 3 months
- Individuals with elevations of porphyrins in plasma or erythrocytes due to other diseases (i.e. secondary porphyrinemia) such as liver and bone marrow diseases
- Patients with any clinically significant comorbid conditions, which in the opinion of the investigator, precludes participation
Where it is running
- University of Alabama, Birmingham — Birmingham, Alabama, United States
- University of California — San Francisco, California, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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