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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01274104
• Other study ID #: ARI-1350-Myalgia
• Status: Withdrawn
• Phase: Phase 1
• First received: January 6, 2011
• Last updated: April 21, 2015
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Myalgia

Intervention

Dietary Supplement:
• Vitamin D3
15,000 IU of Vitamin D3 every day for 14 days

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory value	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	14 days	No