Vitamin D Replacement: The Effect on Statin-Related Myalgias

Not Applicable

Terminated

• Conditions: HMG-CoA Reductase Inhibitors-related Myalgias
• Interventions: Drug: cholecalciferol/placebo

• Registration Number: NCT01022398
• Lead Sponsor: Creighton University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-12-01
• Study Start: 2010-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-09
• Results First Submitted: 2013-03-28
• Results First Submitted QC: 2013-03-28
• Last Update Submitted: 2013-03-28
• Results First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	cholecalciferol/placebo	Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Placebo	cholecalciferol/placebo	Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Cardiac Center at Creighton University; 🇺🇸 Omaha, Nebraska, United States