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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497900
Acronym
KarViDII
Enrollment
45
Registered
2007-07-09
Start date
2007-08-31
Completion date
2011-12-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Vitamin D Deficiency

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.

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

Interventions

DRUGVitamin D

Daily vitamin D (cholecalciferol) tablets and rocaltrol

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Ejection fraction6 months

Secondary

MeasureTime frameDescription
6 minutes walk test6 monthscombined skeletal and cardiac muscle function
Quality of life6 monthsSelf assessed health (MLHFQ)
Biochemical markers6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026