The Effect of Calcium and Vitamin D in Patients With Heart Failure (KarViDII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louise Lind Schierbeck, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00497900
First received: July 6, 2007
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

Previous studies have shown high proportions of vitamin D deficiency among elderly in Denmark. Vitamin D is important for muscular function. The investigators intend to examine if it is possible to improve cardiovascular function in patients with heart failure and vitamin D deficiency by supplementation with vitamin D.


Condition Intervention Phase
Heart Failure
Vitamin D Deficiency
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minutes walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    combined skeletal and cardiac muscle function

  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self assessed health (MLHFQ)

  • Biochemical markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2007
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Calcium and vitamin D
Drug: Vitamin D
Daily vitamin D (cholecalciferol) tablets and rocaltrol
Placebo Comparator: 2
Calcium and placebo (cellulose)
Drug: Vitamin D
Daily vitamin D (cholecalciferol) tablets and rocaltrol

Detailed Description:

Heart failure (HF) is a major course of morbidity and mortality. The prevalence in the Danish population is 1-2% and for age 50 -75 years: 2-3% (1) . It has been estimated that there are currently 6.5 million HF patients in Europe and 5 million in the USA (2) . Lack of vitamin D has been linked to heart disease including ischemic heart disease, heart failure, and hypertension.(3) Vitamin D deficiency is prevalent in the elderly population. Calcium absorption, bone mineralization and muscle function may be impaired. Vitamin D receptors have also been demonstrated in skeletal as well as cardiac muscle(4) . Vitamin D and Parathyroid Hormone (PTH) are closely linked in the calcium metabolic system. In order to maintain serum calcium within range PTH and vitamin D acts together in response to changes in serum-calcium levels. 25(OH)D concentration also being an important factor determining the levels of PTH.(5) Decreasing vitamin D leads to increasing levels of PTH. Hyperparathyroidism in patients with kidney-disease has in numerous studies been linked to cardiovascular disease, left ventricle hypertrophy, and valvular calcification .(6) Aim: Intervention with vitamin D and calcium will improve patients' vitamin D levels and suppress PTH. Thus we hope to find an improved cardiac function and quality of life in the intervention-group.

Comparison: Cardiac function (and other effect parameters - such as self-evaluated health) in the intervention group vs. in the placebo-group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Vitamin D (serum 25-OHD): 50nmol/l or less
  • Heart failure (EF 40% or less, NYHA:2 or more)

Exclusion Criteria:

  • Calcium metabolic disturbances
  • Granulomatous diseases
  • Alcohol or drug abuse
  • Intake of 400IU (or more) vitamin D/day
  • Condition too poor to participate
  • Pregnancy
  • AF with HF 90 or above
  • Mitral insufficiency, degree 3 or above
  • Large cardiac aneurisms
  • Significant aorta stenosis
  • Significant aorta insufficiency
  • Allergy to components
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497900

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Jens-Erik B Jensen, MD, PhD Hvidovre University Hospital
Principal Investigator: Louise Lind Schierbeck, MD Hvidovre University Hospital
  More Information

Publications:
Responsible Party: Louise Lind Schierbeck, MD, research fellow, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00497900     History of Changes
Other Study ID Numbers: 2006-005767-26
Study First Received: July 6, 2007
Last Updated: March 15, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on April 15, 2014