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

Avera McKennan Hospital & University Health Center1 site in 1 countryOctober 2010

ConditionsHyperlipidemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hyperlipidemia
Sponsor: Avera McKennan Hospital & University Health Center
Locations: 1
Primary Endpoint: Brief Pain Inventory value
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Avera McKennan Hospital & University Health Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Brief Pain Inventory value

Time Frame: 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