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

June 2, 2015 updated by: Louise Lind Schierbeck, Hvidovre University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection fraction
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical markers
Time Frame: 6 months
6 months
6 minutes walk test
Time Frame: 6 months
combined skeletal and cardiac muscle function
6 months
Quality of life
Time Frame: 6 months
Self assessed health (MLHFQ)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Study Director: Jens-Erik B Jensen, MD, PhD, Hvidovre University Hospital
  • Principal Investigator: Louise Lind Schierbeck, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-005767-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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