Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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.