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Vitamin D Replacement: The Effect on Statin-Related Myalgias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01022398
Recruitment Status : Terminated (Recruitment slow, funding ended.)
First Posted : December 1, 2009
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date  ICMJE November 27, 2009
First Posted Date  ICMJE December 1, 2009
Results First Submitted Date  ICMJE March 28, 2013
Results First Posted Date  ICMJE May 20, 2013
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Replacement: The Effect on Statin-Related Myalgias
Official Title  ICMJE Vitamin D Replacement: The Effect on Statin-Related Myalgias
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HMG-CoA Reductase Inhibitors-related Myalgias
Intervention  ICMJE Drug: cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Name: Vitamin D3/placebo
Study Arms  ICMJE
  • Experimental: Vitamin D
    Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
    Intervention: Drug: cholecalciferol/placebo
  • Placebo Comparator: Placebo
    Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
    Intervention: Drug: cholecalciferol/placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2009)
100
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022398
Other Study ID Numbers  ICMJE 09-15532
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Schima, MD Creighton University
PRS Account Creighton University
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP