NCT00997269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

4.8 years

First QC Date

October 16, 2009

Last Update Submit

April 28, 2016

Conditions

PainSorenessWeaknessFatigue

Keywords

CoQ-10statinmuscle paincardiovascular

Outcome Measures

Primary Outcomes (1)

  • Pain scores should be reduced

    8 weeks

Study Arms (2)

CoQ-10 supplementation

EXPERIMENTAL
Dietary Supplement: Co-enzyme Q-10

CoQ-10 placebo supplementation

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Co-enzyme Q-10DIETARY_SUPPLEMENT

Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month

Also known as: ubiquinone
CoQ-10 supplementation
PlaceboDIETARY_SUPPLEMENT

Patients will be supplemented with CoQ-10 placebo 1 time daily for one month

CoQ-10 placebo supplementation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University GCRC

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

PainAstheniaFatigueMyalgia

Interventions

Ubiquinone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Study Officials

  • Giuseppe Caso, MD, PhD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

US(1)