Benefit of CoQ-10 in Patients on Statins (CoQ-10)
|Pain Soreness Weakness Fatigue||Dietary Supplement: Co-enzyme Q-10 Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Benefit of CoQ-10 in Patients on Statins|
- Pain scores should be reduced [ Time Frame: 8 weeks ]
|Study Start Date:||September 2009|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: CoQ-10 supplementation||
Dietary Supplement: Co-enzyme Q-10
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
Other Name: ubiquinone
|Placebo Comparator: CoQ-10 placebo supplementation||
Dietary Supplement: Placebo
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
Specific Aim 1: to demonstrate that supplementation with coQ10 in patients treated with statins ameliorates symptoms of muscle pain and fatigue and improves energy metabolism and muscle function.
This objective will be achieved in a randomized, placebo-controlled double blind trial by assessing the degree of muscle symptoms and interference of pain with daily activities, aerobic capacity, and muscle function before and after supplementation with either coQ10 or placebo in groups of statin-treated subjects.
Specific Aim 2: to examine changes at a molecular/cellular level that are associated with improved pain and muscle function in statin-treated subjects supplemented with coQ10.
This aim will be addressed by analyzing muscle biopsies taken from statin-treated patients before and after supplementation with coQ10 or placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997269
|United States, New York|
|Stony Brook University GCRC|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Giuseppe Caso, MD, PhD||Stony Brook University|