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Completed

NCT Number: NCT01636570

Vitamin D3 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).

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Key information

Conditions

Heart Failure Avitaminosis Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Congestive Heart Failure Deficiency Diseases Heart Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Heart Institute of Montana, Missoula, Montana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator: Sugar Pill

Drug

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

Vitamin D3 (cholecalciferol)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

Sponsors and collaborators

Lead sponsor

Heidi Moretti, MS, RD

Other

Collaborators

  • Saint Patrick Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2012
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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