Condition category
Circulatory System
Date applied
25/06/2008
Date assigned
31/07/2008
Last edited
02/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Klaus Witte

ORCID ID

Contact details

Division of Cardiovascular and Diabetes Research
LIGHT building
University of Leeds
Leeds
LS2 9JT
United Kingdom
klauswitte@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Examining the pleiotropic actions of vitamin D supplementation in patients with chronic heart failure

Acronym

Study hypothesis

Chronic heart failure (CHF) is a condition characterised by symptoms of exercise intolerance due to shortness of breath and fatigue. Despite recent advances, patients suffer an inexorable decline in quality of life, have frequent hospital admissions, and a high yearly mortality rate. Cardinal features of CHF include heart muscle weakness (left ventricular dysfunction [LVSD]), muscle wasting and fatigue, neurohormonal activation with increased sympathetic activity, immune activation, insulin resistance, and peripheral vascular dysfunction with increased vascular resistance. In addition to its known effects on bone and mineral metabolism, vitamin D has recently been shown to be important in normal muscle function (both heart and skeletal muscle), control of immune function, insulin production and release and arterial relaxation, and low vitamin D levels are associated with high parathyroid levels which contribute to renal failure and salt imbalance. CHF patients are frequently vitamin D deficient, which might contribute to their ongoing symptoms. We want to find out if supplementing vitamin D deficient CHF patients with high-dose vitamin D for 12 months improves their heart function, quality of life, exercise tolerance, immune activation renal function and peripheral vascular function.

On 17/04/2012 the following changes were made to the trial record:
1. The anticipated end date was changed from 31/12/2012 to 01/05/2012 and the trial is in follow-up phase.
2. The sources of funding field was updated. The previous text was 'British Heart Foundation (BHF) (UK) - application in progress; National Institute for Health Research (NIHR) (UK) - Clinical Scientist Award for Applied Clinical Research: application in progress'

Ethics approval

Leeds West Research Ethics Board – approval pending, date of submission 17/07/2008, ref: 08/H1307/94

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic heart failure

Intervention

100 µg vitamin D or placebo per day for 12 months

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin D supplementation

Primary outcome measures

Left ventricular function assessed at baseline and 12 months, measured by cardiac magnetic resonance

Secondary outcome measures

1. Symptom status (New York Heart Association status), measured at baseline, 1 month, 4 months, 8 months and 12 months
2. Exercise tolerance, measured at baseline and 12 months
3. Quality of life (Minnesota living with heart failure questionnaire, European Quality of Life instrument [EQ5D] and a 19-item Likert scale index [CASP-19]), measured at baseline, 1 month, 4 months, 8 months and 12 months
4. Flow-mediated dilatation, measured at baseline and 12 months
5. Immune status, measured at baseline and 12 months
6. Insulin resistance, measured at baseline and 12 months
7. Autonomic activation (measured by heart rate variability), measured at baseline and 12 months
8. Renal function, measured at baseline, 1 month, 4 months, 8 months and 12 months
9. B-type natriuretic peptide (BNP), measured at baseline, 1 month, 4 months, 8 months and 12 months

Overall trial start date

01/01/2009

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Class II and III heart failure due to left ventricular systolic dysfunction (left ventricular ejection fraction less than or equal to 40%)
2. Stable symptoms for 3 months on maximally tolerated medical therapy with no recent change in medication
3. Able to give informed written consent
4. Aged greater than 18 years, both sexes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Currently taking (or have taken in the previous 3 months) calcium or other vitamin supplements
2. Currently prescribed amlodipine or other calcium channel antagonists (intake of spironolactone will be recorded)
3. CHF due to untreated valvular heart disease
4. History of primary hyperparathyroidism, sarcoidosis, tuberculosis or lymphoma
5. Vitamin D levels greater than 50 nmol/l

Recruitment start date

01/01/2009

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Cardiovascular and Diabetes Research
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Room 1.110
10th Floor Worsley Building
Leeds
LS2 9JT
United Kingdom
r.e.desouza@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

Josphine Lansdell trust via the British Medical Association (BMA) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes