Hyperlipidemia
Conditions
Keywords
statin-related myalgia, high cholesterol
Brief summary
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.
Detailed description
Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).
Interventions
DIETARY_SUPPLEMENTVitamin D3
15,000 IU of Vitamin D3 every day for 14 days
OTHERPlacebo
Placebo
Sponsors
Avera McKennan Hospital & University Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory value | 14 days | Decrease in the level of muscle pain, based on values of Brief Pain Inventory short forms completed at the initial clinic visit and approximately four weeks later at the final clinic visit |
Countries
United States
Outcome results
None listed