Clinical trial NCT00497900: The Effect of Calcium and Vitamin D in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Vitamin D Deficiency
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-07-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: 6 minutes walk test
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Biochemical markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Jens-Erik B Jensen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hvidovre University Hospital
name: Louise Lind Schierbeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available. Danish.
citation: Holick MF. The vitamin D epidemic and its health consequences. J Nutr. 2005 Nov;135(11):2739S-48S. doi: 10.1093/jn/135.11.2739S.
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. doi: 10.1006/cbir.1996.0081.
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. doi: 10.1007/s00198-004-1757-4. Epub 2004 Nov 16.
citation: Horl WH. The clinical consequences of secondary hyperparathyroidism: focus on clinical outcomes. Nephrol Dial Transplant. 2004 Aug;19 Suppl 5:V2-8. doi: 10.1093/ndt/gfh1049.