Vitamin D Replacement: The Effect on Statin-Related Myalgias
NCT ID: NCT01022398
Last Updated: 2013-05-20
Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2010-02-28
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin D
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Placebo
Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Interventions
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cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients aged 19-89 years old
* Men and women (not of childbearing potential)
* Patients receiving statins with concomitant ezetimibe
Exclusion Criteria
* receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
19 Years
89 Years
ALL
No
Sponsors
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Creighton University
OTHER
Responsible Party
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Principal Investigators
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Susan Schima, MD
Role: PRINCIPAL_INVESTIGATOR
Creighton University
Locations
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The Cardiac Center at Creighton University
Omaha, Nebraska, United States
Countries
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Other Identifiers
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09-15532
Identifier Type: -
Identifier Source: org_study_id
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