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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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laval University
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Brief 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.

Condition or disease Intervention/treatment Phase
HMG COA Reductase Inhibitor Adverse Reaction Drug: Vitamin D Drug: Placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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 Drug: Placebo
Participants will receive placebo (lactose 100 mg) for 3 months.




Primary Outcome Measures :
  1. Change in pain score [ Time Frame: Change from baseline at 2 months ]
  2. Change in muscle function testing [ Time Frame: Change from baseline at 2 months ]
    Strenght and endurance evaluation


Secondary Outcome Measures :
  1. Change in muscle histology [ Time Frame: Change from baseline at 2 months ]
    Histological, ultrastructural and metabolic assessment of muscle biopsy.

  2. Change in pain score [ Time Frame: Change from baseline at 5 months ]
  3. Change in muscle function testing [ Time Frame: Change from baseline at 5 months ]
  4. Change in muscle histology [ Time Frame: Change from baseline at 5 months ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Canada, Quebec
Centre hospitalier universitaire de Québec - CHUL
Québec, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Laval University
Investigators
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

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01493648     History of Changes
Other Study ID Numbers: MOP 114917
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by CHU de Quebec-Universite Laval:
statins
side effects
muscle
vitamin D
biopsy
strength
fatigue

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents