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

NCT03289637 | Unknown DMC

• 1 other identifier: D-88538-Sw
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Influence on quality of life in patients with heart failure by the intervention

  Follow-up 12 months after stop of intervention

Other Outcomes (3)

• Influence on quality of life in patients with heart failure by the intervention

  Follow-up 12 months after termination of the intervention

• Influence on symptoms of depression in patients with heart failure by the intervention

  Follow-up 12 months after termination of intervention

• Influence on perceived fatigue in patients with heart failure by the intervention

  Follow-up 12 months after termination of the intervention

Study Arms (2)

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.

Dietary Supplement: Vitamin D

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.

Dietary Supplement: Vitamin D

Interventions

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

Active intervention; Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Dept of Cardiology, University Hospital of Linköping

Linköping, 58191, Sweden

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Urban Alehagen, Prof

  University of Linköping

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urban Alehagen, Prof

CONTACT

+46-10-1030000; urban.alehagen@liu.se

Peter Johansson, Ass Prof

CONTACT

+46-10-1030000; peter.b.johansson@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD.

Model Details: Double blind, parallel, placebo controlled study

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 21, 2017
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)