Vitamin D Replacement in Statin-Induced Myopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vitamin D Replacement in Statin-Induced Myopathy

Conditions
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HMG COA Reductase Inhibitor Adverse Reaction

Intervention / Treatment
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* Drug: Vitamin D (Cholecalciferol )
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study | Drug: Placebo<br>* Standard Placebo made of Lactose 100 mg<br>* Other names: Lactose 100 mg DIN 00501190;|
| Active Comparator: Vitamin D<br>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 )<br>* 10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU<br>* Other names: DIN number 00821772;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lack of need to stop statin medication due to myalgia | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of visual analog pain score |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D