ClinicalTrials.gov
ClinicalTrials.gov Menu

VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure) (VINDICATE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03416361
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
KK Witte, University of Leeds

Brief Summary:
VINDICATE 2 will be a randomised, placebo-controlled, parallel group, double-blind study of vitamin D versus placebo in otherwise optimally-managed patients with CHF due to LVSD and vitamin D deficiency (<50nmol/L). The intervention will be a daily dose of 4000IU (100µg) per day or matching placebo for a minimum of 2 years and a maximum of 4 years.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Dietary Supplement: 4000IU Vitamin D3 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation on Hospitalisation and Mortality in Patients With Heart Failure): Multicentre, Phase III, Randomised Placebo-controlled Trial
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
4000IU Vitamin D3 as two 50mcg tablets per day
Dietary Supplement: 4000IU Vitamin D3
Chewable blackcurrant flavoured tablets (two per day)

Placebo Comparator: Control
Placebo - two chewable blackcurrant flavoured tablets per day
Dietary Supplement: 4000IU Vitamin D3
Chewable blackcurrant flavoured tablets (two per day)




Primary Outcome Measures :
  1. Combined heart failure hospitalisation and total mortality [ Time Frame: 24 months ]
    Time to death or first hospitalisation for heart failure


Secondary Outcome Measures :
  1. Total mortality [ Time Frame: 24 months ]
    Time to death

  2. Cost effectiveness [ Time Frame: 24 months ]
    ICER for vitamin D

  3. Change in patient quality of life [ Time Frame: 24 months ]
    EQ5D - 5L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVSD (LVEF <50%);
  • stable medical and device therapy for >3mths;
  • 25[OH]vitamin D3 <50nmol/L
  • At least one of: recent (<1 year) hospitalisation for HF, high dose loop diuretic requirement (>80mg daily furosemide equiv), diabetes mellitus, ischaemic aetiology

Exclusion Criteria:

  • Unwilling/unable to sign consent,
  • Severe cognitive impairment,
  • Severe COPD,
  • Anaemia,
  • Other life-threatening co-morbidity (in the opinion of the local co-investigator),
  • Known and active sarcoidosis or tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416361


Contacts
Contact: Klaus K Witte, MD k.k.witte@leeds.ac.uk
Contact: Klaus Witte 00441133926642

Locations
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Sponsors and Collaborators
University of Leeds

Responsible Party: KK Witte, Senior Lecturer in Cardiology, University of Leeds
ClinicalTrials.gov Identifier: NCT03416361     History of Changes
Other Study ID Numbers: 224168
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data to be made available from the Leeds Institute of Data Analytics

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KK Witte, University of Leeds:
Left ventricular dysfunction
Vitamin D

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents