Trial record 12 of 155 for:    Open Studies | "Hydroxymethylglutaryl-CoA Reductase Inhibitors"

Benefit of CoQ-10 in Patients on Statins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997269
First received: October 16, 2009
Last updated: August 11, 2011
Last verified: August 2011
  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:

  1. 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:

  1. diagnosis of cancer;
  2. acute illness of any sort;
  3. hemoglobin less than 12,
  4. creatinine greater than 1.5 mg/dl;
  5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
  6. use of certain medications or nutritional supplements within the past month;
  7. untreated hypertension (diastolic BP> 100 mm HG);
  8. diagnosis of diabetes mellitus (fasting blood glucose > 126 mg/dl);
  9. untreated hypothyroidism;
  10. overt congestive heart failure (by physical exam);
  11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
  12. bleeding disorders;
  13. history of adverse reactions besides myopathy associated with the use of statins;
  14. any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
  15. plasma CPK levels > 3 times the upper normal limit; OR
  16. congenital myopathies and/or neuromuscular degenerative diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014