A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.

Key facts

Study ID

NCT01274104

Run by

Avera McKennan Hospital & University Health Center

People needed

0

Starts

2010-10-01

Expected to finish

2011-07-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women who are between the ages of 18 and 88 years old
• A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)

You may not qualify if…

• Women who are pregnant, breastfeeding or planning to become pregnant
• Morbidly obese with a BMI >40 kg/m2
• Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
• Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
• Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
• Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
• Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits

Where it is running

• Avera Research Institute — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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