Status:
COMPLETED
Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
Lead Sponsor:
Mark Lebwohl
Conditions:
Pseudoxanthoma Elasticum
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in subjects with pseud...
Detailed Description
Pseudoxanthoma elasticum (PXE) is a systemic connective tissue disorder involving elastic fiber calcification and fragmentation with major clinical manifestations occurring in the cutaneous, ocular an...
Eligibility Criteria
Inclusion
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- If female of child bearing potential, the subject has a negative urine pregnancy test at the first visit, and agrees to use an approved method of contraception (hormonal contraceptives \[birth control pills, implants \[Norplant\] or injections \[DepoProvera\]); intrauterine device (IUD); two forms of barrier methods \[condoms and diaphragm\]; or abstinence (no sexual activity) throughout the entire study
- Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification of elastic fibers)
- Subject has a clinical disease severity grade of at least "1" (Poorly defined, barely visible macules) at screening.
- Normal kidney function tests
Exclusion
- Any subject who is pregnant or becomes pregnant during the study
- Subjects with a serum creatinine greater than 1.6 mg/dL
- Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria
- Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on dialysis
- Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism
- Subjects with acute gout
- Subjects with malabsorption, or osteomalacia
- Subjects on diuretics, magnesium containing antacids, or anabolic steroids
- Subjects with Cushing's syndrome
- Subjects receiving lithium and those with significant psychiatric disorders that would likely interfere with participation in this study
- Subjects taking anti-seizures medications and anti-arrhythmics medications
- Subjects on tetracycline or metronidazole and ace inhibitors
- Subjects taking cyclosporine or calcineurin inhibitors
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01525875
Start Date
August 1 2012
End Date
March 1 2015
Last Update
March 10 2021
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029