This trial is active, not recruiting.

Condition chronic heart failure
Treatment vitamin d
Phase phase 2
Sponsor University of Leeds
Start date August 2012
End date October 2015
Trial size 250 participants
Trial identifier NCT01619891, MR/J00281X/1


Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Vitamin D 100mcg per day
vitamin d
100mcg per day
(Placebo Comparator)
Standard optimal therapy
vitamin d
100mcg per day

Primary Outcomes

6 minute walk distance
time frame: After one year

Secondary Outcomes

Left ventricular function by Cardiac Magnetic Resonance
time frame: At one year
Peak exercise capacity
time frame: At one year
Biochemical changes
time frame: At one year (but also throughout)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Class II or III CHF - Stable symptoms (on otherwise optimally tolerated medical therapy) - Able to give written informed consent Exclusion Criteria: - Currently taking vitamin D supplementation - Untreated valvular heart disease - Existing class I indication for vitamin D therapy - History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia - Heart failure due to anaemia or thyrotoxicosis - Renal failure (GFR <30l/min)

Additional Information

Official title VitamIN D Treating patIents With Chronic heArT failurE
Principal investigator Klaus K Witte, MD
Description This is an RCT of vitmain D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Leeds.