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
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: 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 July 29, 2014