Vitamin D Replacement: The Effect on Statin-Related Myalgias

Stopped early · Not applicable · Has a placebo group

Conditions studied: HMG-CoA Reductase Inhibitors-related Myalgias

In brief

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.

Key facts

Study ID

NCT01022398

Run by

Creighton University

People needed

4

Starts

2010-02-01

Expected to finish

2011-06-01

Last updated by the study team

2013-05-20

Who can join

Age: 19 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• The Cardiac Center at Creighton University — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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