Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms

Vitamin D2 (Ergocalciferol) is approved by the FDA to treat Vitamin D deficiency and will be given according to approved labeling. This drug has not been systematically studied to test the potential benefits of Vitamin D in patients who suffer from statin-induced muscle pain. Vitamin D2 is the current standard of care for treating vitamin D deficiency. Since the investigators are using Vitamin D2 therapy to treat vitamin D deficiency, and because our trial is a pilot study, the data will not be submitted to the FDA for consideration of changing the labeled indications for Vitamin D2 therapy.

This is a randomized, double-blinded, and placebo-controlled pilot study that will only be performed at CSMC. 40 females with moderate to severe myopathic pain while on Simvastatin will be enrolled in this study and will be randomized at a 1:1 ratio. Patients who will be approached are considering an alternative statin medication as part of their clinical care to address their muscle pain.

Participants will be recruited from the investigators' clinic patients. The study will be discussed with a patient during clinical visit by the treating doctor. Interested individuals will be provided with a copy of the consent form to take home for review with friends, family, and other physicians. The patient may then call the study staff to set a study appointment or enroll in the study during the clinical visit. A study investigator will discuss the study with the patient and ask the patient to read through the consent. The investigator will encourage the patient to ask any questions or discuss any concerns she might have.

If the consenting investigator is also the patient's treating doctor, the consenting investigator will request that the study coordinator approach the patient to determine the patient's interest in the study in order to avoid a conflict of interest. The coordinator will explicitly tell the patient that the patient's participation in the study is completely voluntary and that the patient's medical care will not be affected should she choose not to participate.

Participation in this study will be approximately 8 weeks. 20 participants will be randomized to the treatment group and 20 to the placebo group. The treatment group will receive Vitamin D2 therapy at 50,000 IU for 8 weeks (once per week) while the placebo group will receive a placebo pill (once per week) that is identical in nature. Participants have 2 study visits respectively at Week 0 and Week 8, and 1 phone follow-up visit at Week 1. In addition to the administration of Vitamin D2 or placebo mentioned above, other study procedures include informed consent, physical exam, questionnaires (brief pain assessment, and SF-12 to assess limitations on physical activity), review of medical records, medication and supplement review, blood draw, and phone followup. Subjects will be asked to stop any supplemental Vitamin D therapy to maintain an equal dose within patients in the Vitamin D2 and placebo group.