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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Québec, CHU de Québec.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laval University
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01493648
First received: November 29, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
HMG COA Reductase Inhibitor Adverse Reaction
Drug: Vitamin D
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Change in pain score [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]
  • Change in muscle function testing [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]
    Strenght and endurance evaluation


Secondary Outcome Measures:
  • Change in muscle histology [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]
    Histological, ultrastructural and metabolic assessment of muscle biopsy.

  • Change in pain score [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]
  • Change in muscle function testing [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]
  • Change in muscle histology [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D Drug: Vitamin D
Participants will receive weekly doses of 40,000 IU of vitamin D for 3 months.
Other Name: Cholecalciferol, D-tabs
Placebo Comparator: Placebo Drug: Placebo
Participants will receive placebo (lactose 100 mg) for 3 months.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • statin therapy
  • healthy and sedentary or moderately physical active

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493648

Contacts
Contact: Nathalie Laflamme, MSc 418-656-4141 ext 47117 Nathalie.Laflamme@crchul.ulaval.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Québec - CHUL Not yet recruiting
Québec, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Canadian Institutes of Health Research (CIHR)
Laval University
Investigators
Principal Investigator: Denis R Joanisse, PhD Laval University
Principal Investigator: Jean Bergeron, MD Centre Hospitalier Universitaire de Québec, CHU de Québec
Principal Investigator: Jérôme Frenette, PhD Centre Hospitalier Universitaire de Québec, CHU de Québec
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01493648     History of Changes
Other Study ID Numbers: MOP 114917
Study First Received: November 29, 2011
Last Updated: December 14, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
statins
side effects
muscle
vitamin D
biopsy
strength
fatigue

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014