Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2007-09-30
2013-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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1
300 mg CoQ10 chewable wafer twice a day
Coenzyme Q10
300 mg CoQ10 twice a day for 48 weeks
2
Chewable placebo wafer twice a day for 24 weeks with crossover to 300mg CoQ10 twice a day for weeks 24-48.
Coenzyme Q10
300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
Interventions
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Coenzyme Q10
300 mg CoQ10 twice a day for 48 weeks
Coenzyme Q10
300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Memorial Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sharon Plank, MD
Role: PRINCIPAL_INVESTIGATOR
John P. Murtha Neuroscience and Pain Institute
Locations
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John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, United States
Countries
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References
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Hendler SS, Rorvik D, eds. PDR for Nutritional Supplements. Montvale, NJ: Thomson PDR; 2001:105-106.
Chaudhuri A, Behan PO. Fatigue in neurological disorders. Lancet. 2004 Mar 20;363(9413):978-88. doi: 10.1016/S0140-6736(04)15794-2.
Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. doi: 10.1080/10715760290021315.
Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. doi: 10.2174/0929867033456882.
Bhagavan HN, Chopra RK. Coenzyme Q10: absorption, tissue uptake, metabolism and pharmacokinetics. Free Radic Res. 2006 May;40(5):445-53. doi: 10.1080/10715760600617843.
Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50. doi: 10.1001/archneur.59.10.1541.
Huntington Study Group. A randomized, placebo-controlled trial of coenzyme Q10 and remacemide in Huntington's disease. Neurology. 2001 Aug 14;57(3):397-404. doi: 10.1212/wnl.57.3.397.
Jones K, Hughes K, Mischley L, McKenna DJ. Coenzyme Q-10: efficacy, safety, and use. Altern Ther Health Med. 2002 May-Jun;8(3):42-55; quiz 56, 138. No abstract available.
Lagendijk J, Ubbink JB, Vermaak WJ. Measurement of the ratio between the reduced and oxidized forms of coenzyme Q10 in human plasma as a possible marker of oxidative stress. J Lipid Res. 1996 Jan;37(1):67-75.
Other Identifiers
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05-19
Identifier Type: -
Identifier Source: org_study_id
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