Vitamin D Deficiency Clinical Trial
Official title:
Supplementation With Vitamin D to Patients With Heart Failure. Effects on Symptoms, Quality-of-life and Disease Processes.
In 200 patients with documented systolic heart failure give supplementation with vitamin D in
those with a 25-OH- vitamin D < 50nmol/L - or placebo.
In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in
those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.
Intervention time 12 months. Biomarkers of heart function, quality of life, and
hospitalisation will be analysed.
In a population with a systolic heart failure with an EF<40%, the levels of vitamin D will be
analysed. In those with a 25-OH-vitamin D level <50nmol/L the patients that accept
participation, will be randomised into active supplementation as described below, or placebo.
- In those with a 25-OH-vitamin D level <25nmol/L there will be a supplementation of
2400IU daily
- In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU
daily,
- or placebo. Thus based on the basal level of vitamin D the screened patients will either
be excluded due to high level of vitamin D, or given one ot the two options of vitamin D
dosage based on the basal patient level - or placebo.
The intervention time will be 12 months. In the project 200 heart failure patients will be
included. Blood samples including heart failure biomarkers, and biomarkers for inflammation
and oxidative stress will be drawn at 3,6, 9 and 12 months.
Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with
Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20
questionnaire, as also hospitalisation during the project time.
Cardiac function according to echocardiography will be analysed at start, and study end.
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