The Effect of Calcium and Vitamin D in Patients With Heart Failure (KarViDII)
Primary Purpose
Heart Failure, Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Calcium and vitamin D
Calcium and placebo (cellulose)
Outcomes
Primary Outcome Measures
Ejection fraction
Secondary Outcome Measures
6 minutes walk test
combined skeletal and cardiac muscle function
Quality of life
Self assessed health (MLHFQ)
Biochemical markers
Full Information
NCT ID
NCT00497900
First Posted
July 6, 2007
Last Updated
June 2, 2015
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00497900
Brief Title
The Effect of Calcium and Vitamin D in Patients With Heart Failure
Acronym
KarViDII
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Calcium and vitamin D
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Calcium and placebo (cellulose)
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Daily vitamin D (cholecalciferol) tablets and rocaltrol
Primary Outcome Measure Information:
Title
Ejection fraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
6 minutes walk test
Description
combined skeletal and cardiac muscle function
Time Frame
6 months
Title
Quality of life
Description
Self assessed health (MLHFQ)
Time Frame
6 months
Title
Biochemical markers
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Erik B Jensen, MD, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Louise Lind Schierbeck, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
14964101
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.
Results Reference
background
PubMed Identifier
16251641
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.
Results Reference
background
PubMed Identifier
8948124
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.
Results Reference
background
PubMed Identifier
15551058
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.
Results Reference
background
PubMed Identifier
15284353
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.
Results Reference
background
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The Effect of Calcium and Vitamin D in Patients With Heart Failure
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