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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition HMG-CoA Reductase Inhibitors-related Myalgias
Intervention Drug: cholecalciferol/placebo
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vitamin D Placebo
Hide Arm/Group 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
Period Title: Overall Study
Started 2 2
Completed 0 0
Not Completed 2 2
Reason Not Completed
Study terminated             2             2
Arm/Group Title Vitamin D Placebo Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
  50.0%
3
  75.0%
>=65 years
0
   0.0%
1
  50.0%
1
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
49  (1.4) 56.5  (16.2) 52.75  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
2
 100.0%
1
  50.0%
3
  75.0%
Male
0
   0.0%
1
  50.0%
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
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
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D Placebo
Hide Arm/Group 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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events Not Collected
Hide Arm/Group Description Adverse Events Not Collected
All-Cause Mortality
Adverse Events Not Collected
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Adverse Events Not Collected
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events Not Collected
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cardiology Research Manager
Organization: Creighton University
Phone: 402-280-4566
EMail: tammyburns@creighton.edu
Layout table for additonal information
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01022398    
Other Study ID Numbers: 09-15532
First Submitted: November 27, 2009
First Posted: December 1, 2009
Results First Submitted: March 28, 2013
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013