Vitamin D3 Supplementation for Heart Failure Patients

Sponsor

Heidi Moretti, MS, RD (Other)

Overall Status

Completed

CT.gov ID

NCT01636570

Collaborator

Saint Patrick Hospital (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Vitamin D Deficiency Cardiomyopathy Congestive Heart Failure	Drug: Placebo Comparator: Sugar Pill Drug: Vitamin D3 (cholecalciferol)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D3 (cholecalciferol) 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) 10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months. Other Names: Bio-tech Pharmacal
Placebo Comparator: Sugar Pill 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 Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months. Other Names: Bio-tech Pharmacal

Arm

Intervention/Treatment

Active Comparator: Vitamin D3 (cholecalciferol)

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)

10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.

Other Names:

Bio-tech Pharmacal

Placebo Comparator: Sugar Pill

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

Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.

Other Names:

Bio-tech Pharmacal

Outcome Measures

Primary Outcome Measures

B type Natriuretic Peptide (BNP) [Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo]
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.

Secondary Outcome Measures

Cardiopulmonary exercise test (CPX) [Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo]
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)
25 hydroxyvitamin D [25 (OH)D] [Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo]
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.
C reactive protein (CRP) [Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo]
CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels.
Serum Calcium [Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo]
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.
6 minute walk test [Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo]
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)
Kansas City Cardiomyopathy Questionnaire [Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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