Vitamin D3 Supplementation for Heart Failure Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Saint Patrick Hospital
Sponsor:
Collaborator:
Saint Patrick Hospital
Information provided by (Responsible Party):
Heidi Moretti, MS, RD, Saint Patrick Hospital
ClinicalTrials.gov Identifier:
NCT01636570
First received: July 3, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Saint Patrick Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo ] [ Designated as safety issue: No ]
    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] [ 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 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo ] [ Designated as safety issue: No ]
    CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels.

  • 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 ] [ Designated as safety issue: Yes ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Bio-tech Pharmacal

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636570

Contacts
Contact: Heidi D Moretti, MS, RD 406-327-3117 hmoretti@saintpatrick.org
Contact: Heidi Boehm, RN 406-329-2717 hboehm@saintpatrick.org

Locations
United States, Montana
International Heart Institute of Montana Recruiting
Missoula, Montana, United States, 59802
Sub-Investigator: Vince Colucci, PharmD         
Principal Investigator: Bradley D Berry, MD         
Sub-Investigator: Heidi D Moretti, MS, RD         
Sub-Investigator: Heidi Boehm, RN         
Saint Patrick Hosptial Not yet recruiting
Missoula, Montana, United States, 59802
Sponsors and Collaborators
Heidi Moretti, MS, RD
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
  More Information

No publications provided

Responsible Party: Heidi Moretti, MS, RD, Co-Investigator, Saint Patrick Hospital
ClinicalTrials.gov Identifier: NCT01636570     History of Changes
Other Study ID Numbers: VitD3HF
Study First Received: July 3, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Saint Patrick Hospital:
Heart Failure
Congestive heart failure
Vitamin D
Cholecalciferol
Cardiomyopathy
Strength
Parathyroid Hormone
Calcium
Quality of Life
C reactive protein
Cardiopulmonary exercise testing
Prognosis

Additional relevant MeSH terms:
Heart Failure
Vitamin D Deficiency
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014