Vitamin D Replacement: The Effect on Statin-Related Myalgias

HMG-CoA Reductase Inhibitors-related Myalgias Clinical Trial

Official title:

Vitamin D Replacement: The Effect on Statin-Related Myalgias

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01022398
• Other study ID #: 09-15532
• Status: Terminated
• Phase: N/A
• First received: November 27, 2009
• Last updated: March 28, 2013
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)

• Patients aged 19-89 years old

• Men and women (not of childbearing potential)

• Patients receiving statins with concomitant ezetimibe

Exclusion Criteria:

• history of alcoholism or malnutrition

• receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels

Study Design

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

Related Conditions & MeSH terms

• HMG-CoA Reductase Inhibitors-related Myalgias
• Myalgia

Intervention

Drug:
• cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months

Locations

Country	Name	City	State
United States	The Cardiac Center at Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy		6 months	No