A Trial of Vitamin D Therapy in Patients With Heart Failure
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Full description
The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- New York Heart Association (NYHA) class II-IV
- Able to walk
- Serum 25OHD level 37.5 ng/ml or less
- Fully titrated on heart failure medications
Exclusion criteria
- Osteoporosis
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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