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Completed

NCT Number: NCT00497900

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Vitamin D

Drug

Daily vitamin D (cholecalciferol) tablets and rocaltrol

Primary outcomes

  1. Ejection fraction

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Acronym: KarViDII

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2007
Registry last updated
Jun 3, 2015

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

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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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