Vitamin D Replacement: The Effect on Statin-Related Myalgias

Creighton University4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HMG-CoA Reductase Inhibitors-related Myalgias

Interventions

cholecalciferol/placeboDRUG

10,000 IU by mouth weekly for 6 months

Eligibility

Sex: ALLMin age: 19 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

The Cardiac Center at Creighton University

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

Data from ClinicalTrials.gov

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