Tests vitamin D supplements in people with heart failure and low vitamin D
Tests daily vitamin D3 against a placebo in adults with heart failure.
Plain-language title generated from the registry record
Registry title: VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)
Key facts
- Where
- Leeds, United KingdomSee the site
Where in United Kingdom
- Leeds General InfirmaryLeeds, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Leeds
- Trial code
- NCT03416361
- Record updated
- 2 November 2022
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Severe cognitive impairment,; Known and active sarcoidosis or tuberculosis; Unwilling/unable to sign consent,; Severe COPD,; Anaemia,; Other life-threatening co-morbidity (in the opinion of the local co-investigator),.