Vitamin D Replacement: The Effect on Statin-Related Myalgias

Creighton University

Status: Terminated

Conditions: HMG-CoA Reductase Inhibitors-related Myalgias

Treatments: Drug: cholecalciferol/placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01022398

09-15532

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 19 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly

Treatment:

Drug: cholecalciferol/placebo

Placebo

Placebo Comparator group

Description:

Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly

Treatment:

Drug: cholecalciferol/placebo