A Trial of Vitamin D Therapy in Patients With Heart Failure

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

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol<br>Nutritional supplement | Dietary Supplement: Cholecalciferol<br>* 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily<br>* Other names: Vitamin D;|
| Placebo Comparator: placebo<br>Weekly placebo plus 800 calcium daily | Dietary Supplement: Cholecalciferol<br>* Weekly placebo plus 800 calcium alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak VO2 | Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity | change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Proximal Muscle Strength | Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension | change from baseline to 6 months | 
| 6 Minute Walk Distance | The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL). | Change from baseline to 6 months | 
| Timed Get Up and Go | stand from chair walk 3 meters, return to chair and sit | Change from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Capacity, Strength