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Benefit of CoQ-10 in Patients on Statins (CoQ-10)

Primary Purpose

Pain, Soreness, Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Co-enzyme Q-10
Placebo
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring CoQ-10, statin, muscle pain, cardiovascular

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stony Brook University GCRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CoQ-10 supplementation

CoQ-10 placebo supplementation

Arm Description

Outcomes

Primary Outcome Measures

Pain scores should be reduced

Secondary Outcome Measures

Full Information

First Posted
October 16, 2009
Last Updated
April 28, 2016
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00997269
Brief Title
Benefit of CoQ-10 in Patients on Statins
Acronym
CoQ-10
Official Title
Benefit of CoQ-10 in Patients on Statins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Soreness, Weakness, Fatigue
Keywords
CoQ-10, statin, muscle pain, cardiovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoQ-10 supplementation
Arm Type
Experimental
Arm Title
CoQ-10 placebo supplementation
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Co-enzyme Q-10
Other Intervention Name(s)
ubiquinone
Intervention Description
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
Primary Outcome Measure Information:
Title
Pain scores should be reduced
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Caso, MD, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University GCRC
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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Benefit of CoQ-10 in Patients on Statins

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