Vitamin D Replacement: The Effect on Statin-Related Myalgias

This study has been terminated.
(Recruitment slow, funding ended.)
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01022398
First received: November 27, 2009
Last updated: March 28, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
HMG-CoA Reductase Inhibitors-related Myalgias
Drug: cholecalciferol/placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement: The Effect on Statin-Related Myalgias

Resource links provided by NLM:


Further study details as provided by Creighton University:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Drug: cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Name: Vitamin D3/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
Drug: cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Name: Vitamin D3/placebo

  Eligibility

Ages Eligible for Study:   19 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022398

Locations
United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Susan Schima, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01022398     History of Changes
Other Study ID Numbers: 09-15532
Study First Received: November 27, 2009
Results First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Vitamin D3
HMG-CoA reductase inhibitors (statin)-related myalgias

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014