The impact of vitamin D supplementation in chronic heart failure

ISRCTN	ISRCTN17873085
DOI	https://doi.org/10.1186/ISRCTN17873085
Secondary identifying numbers	N/A

Submission date: 25/06/2008
Registration date: 31/07/2008
Last edited: 22/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Klaus Witte
Scientific

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

Email	klauswitte@hotmail.com

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Examining the pleiotropic actions of vitamin D supplementation in patients with chronic heart failure
Study objectives	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(s)	Leeds West Research Ethics Board approval pending, date of submission 17/07/2008, ref: 08/H1307/94
Health condition(s) or problem(s) studied	Chronic heart failure
Intervention	100 µg vitamin D or placebo per day for 12 months
Intervention type	Supplement
Primary outcome measure	Left ventricular function, assessed by cardiac magnetic resonance at baseline and 12 months
Secondary outcome measures	1. Symptom status (New York Heart Association status), measured at baseline, 1, 4, 8 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, 4, 8 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 at baseline and 12 months 8. Renal function, measured at baseline, 1, 4, 8 and 12 months 9. B-type natriuretic peptide (BNP), measured at baseline, 1, 4, 8 and 12 months
Overall study start date	01/01/2009
Completion date	01/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Room 1.110
10th Floor Worsley Building
Leeds
LS2 9JT
England
United Kingdom

Email	r.e.desouza@leeds.ac.uk
Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Other

Josephine Lansdell Trust via the British Medical Association (BMA) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

22/05/2017: No publications found, verifying study status with principal investigator.