Vitamin D Replacement in Statin-Induced Myopathy

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Information provided by (Responsible Party):
Dr. Mark Sherman, McGill University Health Center Identifier:
First received: July 20, 2011
Last updated: April 6, 2015
Last verified: April 2015

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:

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 ]

Enrollment: 0
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 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.


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

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.


  • 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
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Please refer to this study by its identifier: NCT01400009

Canada, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Study Chair: Mark H Sherman, MD,CM McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Mark Sherman, Associate Professor (Clinical), Dept of Medicine, McGill University Health Center Identifier: NCT01400009     History of Changes
Other Study ID Numbers: D-STAT-2010
Study First Received: July 20, 2011
Last Updated: April 6, 2015
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 02, 2015