NCT01493648

Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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 explored. Also, the investigators will assess the potential usefulness of vitamin D supplementation in a randomized control trial.

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 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.

Conditions

• HMG COA Reductase Inhibitor Adverse Reaction

Interventions

Type	Name	Description
DRUG	Vitamin D	Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.
DRUG	Placebo	Participants will receive placebo (lactose 100 mg) for 3 months.

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2011-12-16
• Last updated: 2016-01-27

Locations

1 site across 1 country: Canada