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VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619891
First Posted: June 14, 2012
Last Update Posted: December 4, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
KK Witte, University of Leeds
  Purpose
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.

Condition Intervention Phase
Chronic Heart Failure Dietary Supplement: Vitamin D Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VitamIN D Treating patIents With Chronic heArT failurE

Resource links provided by NLM:


Further study details as provided by KK Witte, University of Leeds:

Primary Outcome Measures:
  • 6 minute walk distance [ Time Frame: After one year ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 253
Study Start Date: August 2012
Study Completion Date: January 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Vitamin D 100mcg per day
Dietary Supplement: Vitamin D
100mcg per day
Placebo Comparator: Placebo
Standard optimal therapy
Dietary Supplement: Vitamin D
100mcg per day

Detailed Description:
This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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): NCT01619891


Locations
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Klaus K Witte, MD University of Leeds
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: KK Witte, Senior Lecturer in Cardiology, University of Leeds
ClinicalTrials.gov Identifier: NCT01619891     History of Changes
Other Study ID Numbers: MR/J00281X/1
First Submitted: June 12, 2012
First Posted: June 14, 2012
Last Update Posted: December 4, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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