Muscle WeaknessPhase 4NCT01026311
Coenzyme Q10 in Older Athletes Treated With Statin Medications
A Phase 4 study testing Coenzyme q 10 in people with Muscle Weakness and Myalgia, run by Richard Deichmann, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Myalgia, Side Effects of Statins
- What is being tested?
- Coenzyme q 10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 50 years of age, male or female.
- Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
- Self-Described Athletes with any of the following characteristics:
- Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment
- Regular exercise activity of at least 45 minutes duration 5 times per week
Who cannot join
- Use of coenzyme Q10 during the preceding two months.
- CPK level at baseline greater than two times the upper limits of normal
- LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
- LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.
- Conditions
- Muscle Weakness, Myalgia, Side Effects of Statins
- Being tested
- Coenzyme q 10, placebo
- Keywords
- Coenzyme q10, statins, myalgias, anaerobic threshold, athletic performance
- Medical subject headings
- Muscle Weakness, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme q 10Drug
200 mg of Coenzyme q 10
placeboDrug
1 placebo q d during treatment period
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Coenzyme Q10 | Active comparator | 200mg of coenzyme Q10 Receives: Drug: Coenzyme q 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population
Measured: The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Deichmann, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Deichmann, MD, Ochsner Health System
- Investigators
- Richard Deichmann, MD, Principal investigator, Ochsner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026311
- Sponsor's protocol ID
- 09-076
- Status last verified
- May 2012
- First submitted
- 1 Dec 2009
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
- ClinicalTrials.gov ID
- NCT01026311
- Acronym / sponsor ID
- 09-076
- Conditions
- Muscle Weakness, Myalgia, Side Effects of Statins
- Keywords
- Coenzyme q10, statins, myalgias, anaerobic threshold, athletic performance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Richard Deichmann, MDUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Dec 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.
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| Coenzyme Q10 | Active comparator | Drug: Coenzyme q 10200mg of coenzyme Q10 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 50 years of age, male or female.
- Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
- Self-Described Athletes with any of the following characteristics:
Key exclusion criteria (4 listed)
- Use of coenzyme Q10 during the preceding two months.
- CPK level at baseline greater than two times the upper limits of normal
- LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
- LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent
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 |
|---|---|---|
| Coenzyme q 10200 mg of Coenzyme q 10 | Drug | Coenzyme Q10 |
| placebo1 placebo q d during treatment period | Drug | placebo |
Primary outcome
The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population
Time frame: The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.
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 3 May 2012.
Related trials for Muscle Weakness
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
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.
Richard Deichmann, MD principal investigator
Ochsner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme q 10 in people with Muscle Weakness and Myalgia, run by Richard Deichmann, MD 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 5 inclusion and 4 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 3 May 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population (time frame: The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.). 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 3 May 2012.