Vitamin D3 Supplementation for Heart Failure Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636570
• Other study ID #: VitD3HF
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: April 24, 2017
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2017
• Source: Saint Patrick Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Congestive Heart Failure
• Heart Failure
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	International Heart Institute of Montana	Missoula	Montana
United States	Saint Patrick Hosptial	Missoula	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Heidi Moretti, MS, RD	Saint Patrick Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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