Vitamin D Replacement in Statin-Induced Myopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by McGill University Health Center.
Recruitment status was  Recruiting
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

July 20, 2011
July 21, 2011
October 2010
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01400009 on ClinicalTrials.gov Archive Site
reduction of visual analog pain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D Replacement in Statin-Induced Myopathy
Vitamin D Replacement in Statin-Induced Myopathy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HMG COA Reductase Inhibitor Adverse Reaction
  • 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
  • Drug: Placebo
    Standard Placebo made of Lactose 100 mg
    Other Name: Lactose 100 mg DIN 00501190
  • Placebo Comparator: Placebo
    Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Vitamin D (Cholecalciferol )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Mark H Sherman, MDCM 514 934-1934 ext 35090 mark.sherman@mcgill.ca
Canada
 
NCT01400009
D-STAT-2010
No
Dr Mark H Sherman, McGill University Health Centre
McGill University Health Center
Not Provided
Study Chair: Mark H Sherman, MD,CM McGill University Health Center
McGill University Health Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP