Vitamin D3 Supplementation for Heart Failure Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in patients with stable congestive heart failure (Class II or III).

Official Title
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Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients

Conditions
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Heart Failure, Vitamin D Deficiency, Cardiomyopathy, Congestive Heart Failure

Intervention / Treatment
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* Drug: Placebo Comparator: Sugar Pill
* Drug: Vitamin D3 (cholecalciferol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA Heart Failure Class II or II, stable Vitamin D deficiency (32 ng/ml or less) No recent medication changes for 3 months Females of childbearing age must use effective contraceptive if they are sexually active Exclusion Criteria: Hypercalcemia Nephrolithiases Sarcoidosis Acute cardiac insufficiency Pregnancy Breastfeeding Any clinically unstable medical condition Supplements of greater than or equal to 1000 units of vitamin D per day
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3 (cholecalciferol)<br>10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients. | Drug: Vitamin D3 (cholecalciferol)<br>* 10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.<br>* Other names: Bio-tech Pharmacal;|
| Placebo Comparator: Sugar Pill<br>Patients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day. | Drug: Placebo Comparator: Sugar Pill<br>* Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.<br>* Other names: Bio-tech Pharmacal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B type Natriuretic Peptide (BNP) | BNP is a hormone secreted by the heart ventricles, and high concentrations of this hormone occur in heart failure. It is a strong prognostic indicator. | Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (CPX) | Secondary outcome measure will include improvements from baseline in cardiopulmonary function as evaluated by CPX(includes measurement of the change in ventilator efficiency (VE/VCO2), partial pressure of end-tidal CO2 (PETCO2) | Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo | 
| 25 hydroxyvitamin D [25 (OH)D] | Patients with vitamin D deficiency as defined by 25(OH)D of less than 32 ng/ml. 25(OH)D is the most accurate measurement for assessment of vitamin D status. However, ideal ranges for serum 25 (OH)D have not been well established. A recent pharmokinetic study conducted by Hollis, et al, found that 25 OHD levels had to exceed 40 ng/ml and sometimes 50 ng/ml, for the parent substrate (cholecalciferol) to be detectable in the blood (Hollis 2007. IF 25(OH)D levels exceed 150 ng/ml, they will be withdrawn from the study to avoid toxicity. | Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo | 
| C reactive protein (CRP) | CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels. | Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo | 
| Serum Calcium | Measurement of serum calcium levels will help to assess safety of vitamin D treatment. If serum calcium becomes elevated, patients will be withdrawn from the clinical trial. | Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo | 
| 6 minute walk test | The 6 minute walk test is used to measure aerobic activity at baseline and after completion of supplemental vitamin D or placebo. This test is an objective measurement of exercise capacity, and has been shown to be reproducible and a suitable measure for outcome in patients with heart failure (Guyatt). The 6 minute walk test in heart failure patients is strongly associated with vitamin D serum concentrations (p=0.002) and inversely with high sensitivity C reactive protein (hsCRP), an inflammatory marker (p=0.001) | Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo | 
| Kansas City Cardiomyopathy Questionnaire | Measurements of quality of life provide means of measuring prospective benefits of heart failure interventions. The KCCQ is associated with hospitalization and mortality, and is sensitive to changes in heart function with ARB, beta-blocker and ACE inhibitor treatment. | Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Cholecalciferol, Heart Failure, Congestive heart failure, Cardiomyopathy, Strength, Parathyroid Hormone, Calcium, Quality of Life, C reactive protein, Cardiopulmonary exercise testing, Prognosis