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

NCT01493648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-01-27

No results posted yet for this study

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.

Conditions

  • HMG COA Reductase Inhibitor Adverse Reaction

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Laval University

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Denis R Joanisse, PhD · Laval University

  • Jean Bergeron, MD · CHU de Quebec-Universite Laval

  • Jérôme Frenette, PhD · CHU de Quebec-Universite Laval

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493648 on ClinicalTrials.gov