Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).

NCT ID: NCT03289637

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-02-01

Brief Summary

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.

Detailed Description

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active intervention

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: 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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Vitamin D

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients with documented and stable systolic heart failure and connected to an outpatient clinic at the Dept of Cardiology in Linköping, or Jönköping, Sweden, and with a 25-OH-vitamin D <50nmol/L

Exclusion Criteria

• Patients with unstable heart failure
• Patients with significant valvular disease, or ischemic heart disease planned for operation
• Patients with significant renal or /and liver impairment.
• Patients that do not understand that study information, or that are not willing to participate

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Urban Alehagen

Professor, MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Urban Alehagen, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Linköping

Locations

Dept of Cardiology, University Hospital of Linköping

Linköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Urban Alehagen, Prof

Role: CONTACT

urban.alehagen@liu.se

+46-10-1030000

Peter Johansson, Ass Prof

Role: CONTACT

peter.b.johansson@liu.se

+46-10-1030000

Facility Contacts

Peter Wodlin, MD

Role: primary

peter.wodlin@regionostergotland.se

Other Identifiers

D-88538-Sw

Identifier Type: -

Identifier Source: org_study_id