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Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Catherine Buettner, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01032993
First received: December 15, 2009
Last updated: November 7, 2014
Last verified: November 2014
History of Changes
  Purpose

This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.


Condition Intervention Phase
Pain
Weakness
Cramps
Myalgia
Side Effects of Statins
 Dietary Supplement: Coenzyme Q10
Other: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Muscle symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continued statin use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Disability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Coenzyme Q10 Dietary Supplement: Coenzyme Q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Placebo Comparator: Placebo Other: Placebo
Placebo (three chewable tablets) 2 times daily for 4 weeks

Detailed Description:

This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin

Exclusion Criteria:

  • Plasma creatine kinase levels > 3 times the upper normal limit
  • Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit
  • Pregnancy or breastfeeding (a contraindication for statin use)
  • Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
  • Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
  • Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
  • Chest or abdominal surgery within the past six weeks
  • Severe persistent pain related to other causes
  • Unable to complete self-administered questionnaires, or unable to read or converse in English
  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: NCT01032993

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Catherine Buettner
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Catherine Buettner, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Catherine Buettner, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01032993     History of Changes
Other Study ID Numbers: K23 AR055664
Study First Received: December 15, 2009
Last Updated: November 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
CoQ10
Statins
Myalgia
Muscle Pain
Muscle Weakness

Additional relevant MeSH terms:
Coenzyme Q10
Growth Substances
Micronutrients
 Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on February 27, 2015