Vitamin D Replacement in Statin-Induced Myopathy

April 6, 2015 updated by: Dr. Mark Sherman, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • MUHC-Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • DIN number 00821772

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lack of need to stop statin medication due to myalgia
Time Frame: 12 weeks
Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction of visual analog pain score
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Study Chair: Mark H Sherman, MD,CM, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-STAT-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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