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

HMG COA Reductase Inhibitor Adverse Reaction Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• HMG COA Reductase Inhibitor Adverse Reaction

• NCT number: NCT01493648
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Completion date: January 2016