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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Heart Failure Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Calcium and vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Daily vitamin D (cholecalciferol) tablets and rocaltrol

2

Calcium and placebo (cellulose)

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DRUG

Daily vitamin D (cholecalciferol) tablets and rocaltrol

Interventions

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Vitamin D

Daily vitamin D (cholecalciferol) tablets and rocaltrol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No