Heart Failure Clinical Trial

A Trial of Vitamin D Therapy in Patients With Heart Failure

Summary

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

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

64

Study ID:

NCT01125436

Recruitment Status:

Completed

Sponsor:

Case Western Reserve University

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There is 1 Location for this study

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University Hospitals/Case Medical Center
Cleveland Ohio, 44106, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

64

Study ID:

NCT01125436

Recruitment Status:

Completed

Sponsor:


Case Western Reserve University

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