Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
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|ClinicalTrials.gov Identifier: NCT01493648|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|HMG COA Reductase Inhibitor Adverse Reaction||Drug: Vitamin D Drug: Placebo||Not Applicable|
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 drugs. We know very little on the real impact of these muscle symptoms on patient quality of life, especially in relation to muscle strength and endurance.
Patients under statin therapy will stop medication for 2 months. Results from blood sample, muscle function and muscle biopsy (in some participants) will be compared with baseline. Participants will then take vitamin D supplementation or placebo for one month. Thereafter, statin will be reintroduced for two months while continuing vitamin D or placebo supplementation. At the end of that time, measures from blood sample, muscle function and muscle biopsy will be compared with other visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
|Experimental: Vitamin D||
Drug: Vitamin D
Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.
Other Name: Cholecalciferol, D-tabs
|Placebo Comparator: Placebo||
Participants will receive placebo (lactose 100 mg) for 3 months.
- Change in pain score [ Time Frame: Change from baseline at 2 months ]
- Change in muscle function testing [ Time Frame: Change from baseline at 2 months ]Strenght and endurance evaluation
- Change in muscle histology [ Time Frame: Change from baseline at 2 months ]Histological, ultrastructural and metabolic assessment of muscle biopsy.
- Change in pain score [ Time Frame: Change from baseline at 5 months ]
- Change in muscle function testing [ Time Frame: Change from baseline at 5 months ]
- Change in muscle histology [ Time Frame: Change from baseline at 5 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493648
|Centre hospitalier universitaire de Québec - CHUL|
|Québec, Quebec, Canada, G1V 4G2|
|Principal Investigator:||Denis R Joanisse, PhD||Laval University|
|Principal Investigator:||Jean Bergeron, MD||CHU de Quebec-Universite Laval|
|Principal Investigator:||Jérôme Frenette, PhD||CHU de Quebec-Universite Laval|