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Vitamin D Replacement: The Effect on Statin-Related Myalgias

Primary Purpose

HMG-CoA Reductase Inhibitors-related Myalgias

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol/placebo
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HMG-CoA Reductase Inhibitors-related Myalgias focused on measuring Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Cardiac Center at Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 27, 2009
Last Updated
March 28, 2013
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT01022398
Brief Title
Vitamin D Replacement: The Effect on Statin-Related Myalgias
Official Title
Vitamin D Replacement: The Effect on Statin-Related Myalgias
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment slow, funding ended.
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HMG-CoA Reductase Inhibitors-related Myalgias
Keywords
Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Intervention Type
Drug
Intervention Name(s)
cholecalciferol/placebo
Other Intervention Name(s)
Vitamin D3/placebo
Intervention Description
10,000 IU by mouth weekly for 6 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Schima, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cardiac Center at Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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Vitamin D Replacement: The Effect on Statin-Related Myalgias

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