Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE) (NCT01525875) | Clinical Trial Compass
CompletedPhase 2
Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
United States44 participantsStarted 2012-08
Plain-language 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 pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that has been shown in some research to reduce these calcium deposits. This study consists of two parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an open-label, year-long study. In Part 1, qualified subjects will be randomized to receive either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased. Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy; eye examination; bone density test; and photography of skin lesions. Subjects will be evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon completion of the first year, barring any safety concerns, all subjects will be administered magnesium oxide supplements for up to one additional year. Subjects will undergo the same evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 participa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.