Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS

This study has been completed.
Information provided by (Responsible Party):
Jim S Wu, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
First received: October 5, 2012
Last updated: February 3, 2015
Last verified: February 2015
It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using statins. The investigators propose a pilot study to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a parallel arm study to either ubiquinol or placebo over 4 weeks.

Condition Intervention
HMG COA Reductase Inhibitor Adverse Reaction
Dietary Supplement: ubiquinol
Dietary Supplement: placebo
Drug: statin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ubiquinol on the Association of Statins and Mitochondrial Oxidative Capacity Using 31P Magnetic Resonance Imaging

Resource links provided by NLM:

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

Primary Outcome Measures:
  • phosphocreatine recovery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Phosphocreatine recovery as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity

Enrollment: 21
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Statin + placebo
9 patients taking statin medications and placebo.
Dietary Supplement: placebo
placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
Drug: statin
statin was given for 1 month to 21 patients
Active Comparator: Statin + ubiquinol
12 patients on statins and ubiquinol
Dietary Supplement: ubiquinol
ubiquinol supplementation was given for 1 month to 12 patients
Other Name: coenzyme Q10
Drug: statin
statin was given for 1 month to 21 patients

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Persons age 18 years and older who have been advised to use a statin medication by their physician.
  2. Up to ten individuals will have a history of statin myalgia on observed statin rechallenge. All others will have a history (>6 months) of tolerating a statin at a standard starting dose or higher.
  3. All persons will be able to cooperate for a period of 1-2 hours, able to provided informed consent and have no known adverse effects or contraindications to an MRI study.

Exclusion Criteria:

  1. Having diabetes or known lower extremity peripheral vascular disease, as these conditions may interfere with interpretation of the MRI spectroscopy of the lower extremity (the only site we are examining in this study).
  2. Current users of a statin with a recent heart attack, stroke, or revascularization procedure (within the last 1 year) who could be at higher risk of stopping a statin.
  3. Creatine kinase (CK) > 5 x ULN. If CK levels are greater than 3 x ULN, the participant will be given the option of returning for a repeat blood draw at their earliest convenience. Any elevation in CK will be treated per the safety guidelines outlined in section B5.
  4. Alanine transferase (ALT) or aspartate transferase (AST) > 3 x ULN. If ALT and/or AST levels are greater than 3 x ULN, the participant will return for a repeat blood draw at their earliest convenience. If the participant's ALT and/or AST is found elevated at this repeat analysis, they will be withdrawn from the study. Any elevation in ALT and/or AST will be treated per the safety guidelines outlined in section B5.
  5. Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. poorly controlled hypertension; (>170/>100); known creatinine > 2.5 md/dl or GFR < 30; anemia with Hgb < 10, etc.).
  6. Pregnancy or breastfeeding (a contraindication for statin use)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01702987

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Jim S Wu, MD Beth Israel Deaconess
  More Information

Responsible Party: Jim S Wu, Assistant Professor Department of Radiology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01702987     History of Changes
Other Study ID Numbers: 010-31415 
Study First Received: October 5, 2012
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
ubiquinol (coenzyme Q10)

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Coenzyme Q10
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016