Erythropoietic Protoporphyria Clinical Trial
Official title:
Effect of Oral Iron Therapy on Erythrocyte Protoporphyrin Levels in the Erythropoietic Protoporphyrias
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.
This is a clinical trial, which means its purpose is to study an intervention or treatment.
In this study all patients with EPP or XLP will be given a standard dose of iron pills and
monitored for one year. There is currently no effective Food and Drug Administration (FDA)
approved treatment for EPP or XLP in the US. Giving iron to patients with low ferritin (a
measure of body iron stores) levels may help improve their EPP symptoms by decreasing
erythrocyte protoporphyrin levels.
Patients will be asked come to the study site once every three months over the course of a
year for a total of five visits. At these visits the study doctors will check in with
participants and some blood and urine samples will be taken. Participants will not be charged
for any of the lab tests that are being done for part of this study alone. In between these
study visits there will be phone call to check in and see how participants are doing. All
patients in this study will receive iron pills at no cost to them.
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