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Vitamin D Replacement in Statin-Induced Myopathy

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ClinicalTrials.gov Identifier: NCT01400009
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : July 22, 2011
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Sherman, McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment
HMG COA Reductase Inhibitor Adverse Reaction Drug: Vitamin D (Cholecalciferol ) Drug: Placebo

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement in Statin-Induced Myopathy
Study Start Date : October 2010
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. reduction of visual analog pain score [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01400009


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

Responsible Party: Dr. Mark Sherman, Associate Professor (Clinical), Dept of Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01400009     History of Changes
Other Study ID Numbers: D-STAT-2010
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Dr. Mark Sherman, McGill University Health Center:
Statin
HMG COA Reductase Inhibitor
myalgia
vitamin D

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