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lack of enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study |
|
| Vitamin D | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (Cholecalciferol ) | Drug | 10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of visual analog pain score | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
examples:
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| Name | Affiliation | Role |
|---|---|---|
| Mark H Sherman, MD,CM | McGill University Health Centre/Research Institute of the McGill University Health Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUHC-Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Standard Placebo made of Lactose 100 mg |
|
|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |