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

Heart Failure Clinical Trial

— KarViDII  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497900
• Other study ID #: 2006-005767-26
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2007
• Last updated: June 2, 2015
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
Daily vitamin D (cholecalciferol) tablets and rocaltrol

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Holick MF. The vitamin D epidemic and its health consequences. J Nutr. 2005 Nov;135(11):2739S-48S. — View Citation

Hörl WH. The clinical consequences of secondary hyperparathyroidism: focus on clinical outcomes. Nephrol Dial Transplant. 2004 Aug;19 Suppl 5:V2-8. Review. — View Citation

Nielsen OW, Raymond IE, Kirk V, Pedersen F, Bay-Nielsen M. [The epidemiology of heart failure from a Danish perspective]. Ugeskr Laeger. 2004 Jan 19;166(4):243-7. Review. Danish. — View Citation

O'Connell TD, Simpson RU. Immunochemical identification of the 1,25-dihydroxyvitamin D3 receptor protein in human heart. Cell Biol Int. 1996 Sep;20(9):621-4. — View Citation

Pepe J, Romagnoli E, Nofroni I, Pacitti MT, De Geronimo S, Letizia C, Tonnarini G, Scarpiello A, D'Erasmo E, Minisola S. Vitamin D status as the major factor determining the circulating levels of parathyroid hormone: a study in normal subjects. Osteoporos Int. 2005 Jul;16(7):805-12. Epub 2004 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction		6 months	No
Secondary	6 minutes walk test	combined skeletal and cardiac muscle function	6 months	No
Secondary	Quality of life	Self assessed health (MLHFQ)	6 months	No
Secondary	Biochemical markers		6 months	No