An interventional study of Vitamin D in Heart Failure With Reduced Ejection Fraction and Vitamin D Deficiency, sponsored by Linkoeping University. Status unknown at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given. In those randomised to active treatment and with a screening level of 25-OH-vitamin D of \<25nmol/L, an intervention of 2400IE of vitamin D will be given.
Dietary Supplement: Vitamin D
In the group randomised to placebo and with a screening level of 25-OH-vitamin D \<50 mol/L, the participants will be given placebo.
Dietary Supplement: Vitamin D
Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level\<50nmol/L at screening
Reduction in the composite endpoint for heart failure
Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint
Time frame: Follow-up 12 months after stop of intervention
Influence on quality of life in patients with heart failure by the intervention
Effect on health related quality of life as measured by the Euro-QoL-5D Minnesota Living with Heart Failure. Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaires
Time frame: Follow-up 12 months after stop of intervention
Influence on quality of life in patients with heart failure by the intervention
Effect on health related quality of life as measured by Minnesota Living with Heart Failure
Time frame: Follow-up 12 months after termination of the intervention
Influence on symptoms of depression in patients with heart failure by the intervention
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Follow-up 12 months after termination of intervention
Influence on perceived fatigue in patients with heart failure by the intervention
Effect on as measured using the Multidimensional Fatigue Inventory 20
Time frame: Follow-up 12 months after termination of the intervention
Plan to share: No
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Linkoeping University