A Trial of Vitamin D Therapy in Patients With Heart Failure
NCT ID: NCT01125436
Last Updated: 2022-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2008-07-31
2011-09-30
Brief Summary
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Detailed Description
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A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients \> 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cholecalciferol
Nutritional supplement
Cholecalciferol
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
placebo
Weekly placebo plus 800 calcium daily
Cholecalciferol
Weekly placebo plus 800 calcium alone
Interventions
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Cholecalciferol
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
Cholecalciferol
Weekly placebo plus 800 calcium alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to walk
* Serum 25OHD level 37.5 ng/ml or less
* Fully titrated on heart failure medications
Exclusion Criteria
* Primary hyperparathyroidism or hypercalcemia.
* Nephrolithiasis
* Hemo or peritoneal dialysis and/or creatinine of \> 2.5
* Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
* Current illicit drug user or \> 3 alcoholic drinks a day
* Metastatic or advanced cancer
* Myocardial infarction in the preceding 6 months
* Medications which can lower vitamin D levels or bioavailability
50 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Rebecca Boxer, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve Univerity
Locations
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University Hospitals/Case Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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