Text Size

Vitamin D Replacement in Statin-Induced Myopathy

This study is currently recruiting participants.
Verified July 2011 by McGill University Health Center
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01400009
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement in Statin-Induced Myopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • lack of need to stop statin medication due to myalgia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia


Secondary Outcome Measures:
  • reduction of visual analog pain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study
 Drug: Placebo
Standard Placebo made of Lactose 100 mg
Other Name: Lactose 100 mg DIN 00501190
Active Comparator: Vitamin D
Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3
 Drug: Vitamin D (Cholecalciferol )
10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU
Other Name: DIN number 00821772

Detailed Description:

Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male and female adults
  • identified by their physician as having myalgia with their statin medication.

Exclusion Criteria:

  • Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past.
  • Severe myositis
  • Consumption in excess of 14 alcoholic beverages per week
  • Situations which will cause difficulty in interpreting the vitamin D and / or PTH.

examples:

  • Present consumption of vitamin D supplements > 1000 iu daily
  • Renal impairment (Estimated creatinine clearance < 70 ± 14 mL/min/m2 in Males; and < 60 ± 10 mL/min/m2 in Females)
  • Chronic liver disease or impaired liver function
  • Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400009

Contacts
Contact: Mark H Sherman, MDCM 514 934-1934 ext 35090 mark.sherman@mcgill.ca

Locations
Canada, Quebec
MUHC-Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: S Segal, PDt         sharisegal@hotmail.com    
Principal Investigator: Mark H Sherman, MDCM            
Sponsors and Collaborators
McGill University Health Center
Investigators
Study Chair: Mark H Sherman, MD,CM McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr Mark H Sherman, McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01400009     History of Changes
Other Study ID Numbers: D-STAT-2010
Study First Received: July 20, 2011
Last Updated: July 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Statin
HMG COA Reductase Inhibitor
myalgia
vitamin D

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013