Overview

Vitamin D Replacement: The Effect on Statin-Related Myalgias

Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Creighton University
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
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