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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01525875 |
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Date of registration:
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01/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
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Scientific title:
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Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE) |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01525875 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Mark Lebwohl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pseudoxanthoma Elasticum
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Intervention(s)
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Drug: Magnesium Oxide
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Drug: Placebo
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Primary Outcome(s)
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Von Kossa Staining Per Unit Area of Dermis
[Time Frame: up to 2 years]
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Secondary Outcome(s)
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Central Retinal Thickness
[Time Frame: 2 years]
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Number of Participants With a 1-point Decrease of Target Lesions
[Time Frame: up to 2 years]
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VAS - Visual Acuity Score
[Time Frame: 2 years]
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LogMar
[Time Frame: 2 years]
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Secondary ID(s)
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FD-R-0003903
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GCO 09-1157
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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