Benefit of CoQ-10 in Patients on Statins
This study is currently recruiting participants.
Verified August 2011 by Stony Brook University
Sponsor:
Stony Brook University
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997269
First received: October 16, 2009
Last updated: August 11, 2011
Last verified: August 2011
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Purpose
This study will investigate whether a supplement called co-enzyme Q10 can help ease or eliminate some of the side effects that result from taking statin medications. These side effects include muscle pain, fatigue or muscle cramping.
| Condition | Intervention |
|---|---|
|
Pain Soreness Weakness Fatigue |
Dietary Supplement: Co-enzyme Q-10 Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Benefit of CoQ-10 in Patients on Statins |
Resource links provided by NLM:
Further study details as provided by Stony Brook University:
Primary Outcome Measures:
- Pain scores should be reduced [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult men and women 21 years and older taking statin medications for hyperlipidemia under the current National Cholesterol Education Program guidelines (NCEP III) and complaining of myopathic symptoms.
Exclusion Criteria:
- diagnosis of cancer;
- acute illness of any sort;
- hemoglobin less than 12,
- creatinine greater than 1.5 mg/dl;
- liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
- use of certain medications or nutritional supplements within the past month;
- untreated hypertension (diastolic BP> 100 mm HG);
- diagnosis of diabetes mellitus (fasting blood glucose > 126 mg/dl);
- untreated hypothyroidism;
- overt congestive heart failure (by physical exam);
- active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
- bleeding disorders;
- history of adverse reactions besides myopathy associated with the use of statins;
- any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
- plasma CPK levels > 3 times the upper normal limit; OR
- congenital myopathies and/or neuromuscular degenerative diseases.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997269
Contacts
| Contact: Giuseppe Caso, MD, PhD | (631) 444-1790 | gcaso@notes.cc.sunysb.edu |
| Contact: Teresa Hunt-Goncalves, NP | (631) 444-9362 | thunt_goncalves@notes.cc.sunysb.edu |
Locations
| United States, New York | |
| Stony Brook University GCRC | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Giuseppe Caso, MD 631-444-1790 gcaso@notes.cc.sunysb.edu | |
| Contact: William Lawson, MD (631)444-1060 | |
| Principal Investigator: Giuseppe Caso, MD, PhD | |
| Sub-Investigator: William E Lawson, MD | |
| Sub-Investigator: Margaret A McNurlan, PhD | |
Sponsors and Collaborators
Stony Brook University
Investigators
| Principal Investigator: | Giuseppe Caso, MD, PhD | Stony Brook University |
More Information
No publications provided
| Responsible Party: | Giuseppe Caso, MD, PhD, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT00997269 History of Changes |
| Other Study ID Numbers: | 2008-0436, AT004204 |
| Study First Received: | October 16, 2009 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stony Brook University:
|
CoQ-10 statin muscle pain cardiovascular |
Additional relevant MeSH terms:
|
Asthenia Fatigue Signs and Symptoms Coenzyme Q10 Ubiquinone Hydroxymethylglutaryl-CoA Reductase Inhibitors Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Vitamins Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013