PainCoQ-10NCT00997269
Benefit of CoQ-10 in Patients on Statins
A study testing Co-enzyme Q-10 in people with Pain and Soreness, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Co-enzyme Q-10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University GCRC
Stony Brook, New York, 11794
About this study
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.
Read the 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.
- Being tested
- Co-enzyme Q-10, Placebo
- Keywords
- CoQ-10, statin, muscle pain, cardiovascular
- Medical subject headings
- Pain, Asthenia, Fatigue, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-enzyme Q-10Dietary supplement
Also called ubiquinone
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
PlaceboDietary supplement
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
| Study group | Role | What they receive |
|---|---|---|
| CoQ-10 supplementation | Experimental | Not described Receives: Dietary Supplement: Co-enzyme Q-10 |
| CoQ-10 placebo supplementation | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores should be reduced
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Caso, MD, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997269
- Sponsor's protocol ID
- 2008-0436
- Other IDs
- AT004204
- Acronym
- CoQ-10
- Status last verified
- Apr 2016
- First submitted
- 16 Oct 2009
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of CoQ-10 in Patients on Statins
- ClinicalTrials.gov ID
- NCT00997269
- Acronym / sponsor ID
- CoQ-10 / 2008-0436
- Keywords
- CoQ-10, statin, muscle pain, cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQ-10 supplementation | Experimental | Dietary Supplement: Co-enzyme Q-10 |
| CoQ-10 placebo supplementation | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-enzyme Q-10Also: ubiquinonePatients will be supplemented with 300 mg of CoQ-10 1 time daily for one month | Dietary supplement | CoQ-10 supplementation |
| PlaceboPatients will be supplemented with CoQ-10 placebo 1 time daily for one month | Dietary supplement | CoQ-10 placebo supplementation |
Primary outcome
Pain scores should be reduced
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Caso, MD, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-enzyme Q-10 in people with Pain and Soreness, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores should be reduced (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.