Trials / Completed
CompletedNCT00541164
Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Memorial Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Coenzyme Q10 | 300 mg CoQ10 twice a day for 48 weeks |
| DIETARY_SUPPLEMENT | Coenzyme Q10 | 300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2007-10-10
- Last updated
- 2013-07-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00541164. Inclusion in this directory is not an endorsement.