Benefit of CoQ-10 in Patients on Statins

Pain Clinical Trial

— CoQ-10  

Official title:

Benefit of CoQ-10 in Patients on Statins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997269
• Other study ID #: 2008-0436
• Secondary ID: AT004204
• Status: Completed
• Phase: N/A
• First received: October 16, 2009
• Last updated: April 28, 2016
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Pain
• Soreness
• Weakness

Intervention

Dietary Supplement:
• Co-enzyme Q-10
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
• Placebo
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month

Locations

Country	Name	City	State
United States	Stony Brook University GCRC	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores should be reduced		8 weeks	No