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

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency; Heart Failure

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00497900

2006-005767-26

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Calcium and vitamin D

Treatment:

Drug: Vitamin D

2

Placebo Comparator group

Description:

Calcium and placebo (cellulose)

Treatment:

Drug: Vitamin D