Clinical Trial: Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Coenzyme Q10 (CoQ10) on Subjects With Charcot-Marie-Tooth Disease (CMT):A Double Blind, Randomized, Controlled Trial With an Open Label Follow-up Study

Brief Summary: The object of this research is to test the effectiveness of Coenzyme Q10 (CoQ10) on symptoms of weakness, fatigue, and pain in persons with Charcot-Marie-Tooth disease (CMT).In this study we also intend to examine the impact of daily supplementation on overall quality of life.We are also interested in identifying any differences in serum ratios of CoQ10 in the oxidized and reduced forms.

Detailed Summary:

CoQ10 is an integral part of the electron transport chain in the mitochondria, or the energy production centers of cells. Within recent years, there has been expanding interest in the potential benefits of CoQ10 supplementation on a variety of neuromuscular diseases, some of which involve mitochondrial dysfunction, such as CMT. Daily supplementation may have cytoprotective and neuroprotective properties, which may improve symptoms of weakness, fatigue, and pain, as well as increase quality of life (QOL) among persons with CMT.

With regards to within group comparisons we hypothesize that daily supplementation of CoQ10 taken as a 300 milligram wafer twice a day for 3 months will produce a statistically significant reduction in weakness, fatigue, and pain, along with a significant improvement in QOL as indicated from scores in both standardized physiological and scale measures.

The addition of serum level analysis will help to contextualize clinical results. We hypothesize the ratios of the oxidized and reduced forms of CoQ10 will be modified upon supplementation.


Sponsor: Memorial Medical Center

Current Primary Outcome: Changes in weakness, fatigue and pain in persons with Charcot-Marie-Tooth disease after supplementation with 600 mgs a day of Coenzyme Q10. [ Time Frame: 60 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvements in quality of life in subjects with CMT before and after CoQ10 supplementation. [ Time Frame: 60 weeks ]
  • Measure blood serum levels of the oxidized and reduced forms of CoQ10. [ Time Frame: 60 weeks ]
  • Measure liver function tests [ Time Frame: visits 1, 6, 12 ]


Original Secondary Outcome:

  • Improvements in quality of life in subjects with CMT before and after CoQ10 supplementation. [ Time Frame: 60 weeks ]
  • Measure blood serum levels of the oxidized and reduced forms of CoQ10. [ Time Frame: 60 weeks ]


Information By: Memorial Medical Center

Dates:
Date Received: October 9, 2007
Date Started: September 2007
Date Completion:
Last Updated: July 11, 2013
Last Verified: June 2010