Vitamin D3 Supplementation for Heart Failure Patients

April 24, 2017 updated by: Heidi Moretti, MS, RD

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Missoula, Montana, United States, 59802
        • International Heart Institute of Montana
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B type Natriuretic Peptide (BNP)
Time Frame: 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.
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)
Time Frame: 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)
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]
Time Frame: 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.
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)
Time Frame: 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.
Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
Serum Calcium
Time Frame: 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.
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
Time Frame: 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)
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
Time Frame: 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.
Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidi Moretti, MS, RD

Collaborators

Saint Patrick Hospital

Investigators

  • Principal Investigator: Bradley D Berry, MD, International Heart Institute of Montana
  • Study Director: Heidi D Moretti, MS, RD, Saint Patrick Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (ESTIMATE)

July 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitD3HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Vitamin D3 (cholecalciferol)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe