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
| City: |
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Johnstown |
| State: |
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Pennsylvania |
| Zip Code: |
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15904 |
| Conditions: |
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Charcot Marie Tooth Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Subjects must have a diagnosis of CMT, confirmed by review of medical records by the
study physician
- Subjects can be of either gender
- Subjects must be between the ages of 18 and 75
- Subjects must be able to complete all assessments at the designated time intervals
- Subjects must review and sign the informed consent statement according to Conemaugh
Memorial Medical Center's (CMMC) Institutional Review Board (IRB) guidelines
- Subjects must receive approval from their primary care physician (PCP) to enroll in
the study
- Regarding weakness, fatigue, and pain, subjects must experience at least two of the
three symptoms on most days over the past month
- Regarding weakness, fatigue, and pain, subjects must report experiencing maximum
levels of >/= 3.0 centimeters (cm) on the 10 cm visual analog scale (VAS) for any two
of the three symptoms over the past month
- Female subjects must be willing to practice stable birth control during involvement
in the study
- Subjects must agree to be randomized
Exclusion Criteria:
- Subjects having another general medical condition, which might confound the
assessment of weakness, fatigue, and pain due to CMT
- Subjects taking warfarin or Coumadin
- Subjects who are pregnant, verified by a urine pregnancy test*
- Subjects having a cognitive impairment scoring < 20 on the Mini-Mental State Exam
- Subjects who are currently using CoQ10 supplementation or have used it in the past 6
months
- Subjects with a history of chronic liver disease or other condition causing
malabsorption
- Drug intake that could modify lipid absorption (such as statins)
- Subjects who consume >3 alcoholic drinks per day on more than one occasion per month
- Subjects with abnormal liver function tests as defined through a Hepatic -Function
Panel or a Liver Function Panel
- Women of childbearing age who have had at least one menstrual cycle within the
past 12 months and who have not undergone a sterilization procedure will undergo
a urine pregnancy test at visits 1-10 regardless of group assignment in order to
maintain the single blind. The urine samples will be processed at CMMC's lab
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| NCT ID: |
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NCT00541164 |
| Primary Contact: |
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Principal Investigator
Sharon Plank, MD
John P. Murtha Neuroscience and Pain Institute
Janet Goodard, RN, BC BSN
Phone: 814-269-5288
Email: jgoodar@conemaugh.org
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| Backup Contact: |
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Email: splank@conemaugh.org
Sharon Plank, MD
Phone: 814-269-5204
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| Location Contact: |
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Johnstown, Pennsylvania 15904
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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