Benefit of CoQ-10 in Patients on Statins (CoQ-10)
|ClinicalTrials.gov Identifier: NCT00997269|
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Soreness Weakness Fatigue||Dietary Supplement: Co-enzyme Q-10 Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Benefit of CoQ-10 in Patients on Statins|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
|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
- Pain scores should be reduced [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|