Status:
COMPLETED
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Laval University
Conditions:
HMG COA Reductase Inhibitor Adverse Reaction
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explore...
Detailed Description
Statins are a class of drugs that are widely prescribed to lower blood cholesterol levels. Although they have few side effects, many patients report muscle pain, cramps, and weakness when using these ...
Eligibility Criteria
Inclusion
- statin therapy
- healthy and sedentary or moderately physical active
Exclusion
- Current treatment with other lipid-lowering drugs
- Natural medicine affecting lipid metabolism
- CK levels above the normal range
- Clinical vitamin D deficiency
- Impaired liver or kidney function
- Untreated hypo- or hyperthyroidism
- Treatment with other medications known to increase risk of myopathy
- Existing infection requiring antibiotic therapy
- Consumption of greater than 60 ml of grapefruit juice per day
- Inherited muscle disorders or myopathy
- Polymyositis or inflammatory myopathy
- Use of corticosteroids
- Comorbidities resulting in muscle or bone pain
- History of elevated CK
- Unexplained cramps
- Known sickle cell trait
- Cancer within the 5 years prior to study entry
- Diabetes
- Stroke, coronary artery or peripheral vascular disease
- Physical disability or previous injury interfering with exercise testing
- Pregnant or breastfeeding
- Depression (in last 3 years) or treatment with antidepressants
- Use of anti-psychotic drugs
- Alcohol abuse
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01493648
Start Date
December 1 2011
End Date
January 1 2016
Last Update
January 27 2016
Active Locations (1)
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1
Centre hospitalier universitaire de Québec - CHUL
Québec, Quebec, Canada, G1V 4G2