A Trial of Vitamin D Therapy in Patients With Heart Failure

A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure

The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

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.

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