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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active intervention | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Follow-up 12 months after stop of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Follow-up 12 months after stop of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Follow-up 12 months after termination of the intervention |
| Influence on symptoms of depression in patients with heart failure by the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Urban Alehagen, Prof | Contact | +46-10-1030000 | urban.alehagen@liu.se | |
| Peter Johansson, Ass Prof | Contact | +46-10-1030000 | peter.b.johansson@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Urban Alehagen, Prof | University of Linköping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Cardiology, University Hospital of Linköping | Recruiting | Linköping | 58191 | Sweden |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Double blind, parallel, placebo controlled study
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Neither the participant, nor the care provider will be informed if active supplementation or placebo will be given, nor will blood sample results be open for care provider
Patient Health Questionnaire-9 (PHQ-9) |
| 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 | Follow-up 12 months after termination of the intervention |
| D009750 |
| Nutritional and Metabolic Diseases |