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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497900
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 3, 2015
Information provided by (Responsible Party):
Louise Lind Schierbeck, Hvidovre University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Vitamin D Deficiency Drug: Vitamin D Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Ejection fraction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 6 minutes walk test [ Time Frame: 6 months ]
    combined skeletal and cardiac muscle function

  2. Quality of life [ Time Frame: 6 months ]
    Self assessed health (MLHFQ)

  3. Biochemical markers [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497900

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

Responsible Party: Louise Lind Schierbeck, MD, research fellow, Hvidovre University Hospital Identifier: NCT00497900     History of Changes
Other Study ID Numbers: 2006-005767-26
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: March 2012

Additional relevant MeSH terms:
Heart Failure
Vitamin D Deficiency
Heart Diseases
Cardiovascular Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents