Contact information
Type
Scientific
Primary contact
Dr Miles Witham
ORCID ID
Contact details
Section of Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.witham@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007CV09
Study information
Scientific title
Can high-dose vitamin D supplementation reduce blood pressure and markers of cardiovascular risk in older people with isolated systolic hypertension? A randomised, double-blind, parallel group placebo controlled trial
Acronym
VitDISH
Study hypothesis
That supplementation with 100,000 units of vitamin D3 every 3 months will produce reductions in blood pressure and improvements in markers of vascular health in patients aged greater than 70 years with isolated systolic hypertension.
Ethics approval
Fife and Forth Valley Research Ethics Committee gave approval on the 15th December 2008 (ref: 08/S0501/90)
Study design
Randomised, double-blind, parallel group placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Isolated systolic hypertension
Intervention
100,000 units of vitamin D3 or placebo every 3 months for 1 year.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin D supplementation
Primary outcome measures
Change in office blood pressure at 3 months.
Secondary outcome measures
1. Change in office blood pressure (at 0, 6, 9, 12 months)
2. Change in 24 hour mean blood pressure (at 0, 3, 6, 9, 12 months)
3. Change in B-type natriuretic peptide, high sensitivity C-reactive protein (hsCRP) and homeostatic model assessment (HOMA) index at 0, 3 and 12 months
4. Change in endothelial function measured by flow-mediated dilatation of the brachial artery (FMD) at 0, 3 and 12 months
5. Change in pulse wave velocity at 0, 3 and 12 months
6. Change in 25-hydroxy vitamin D and parathyroid hormome (PTH) levels, cholesterol and triglycerides
Overall trial start date
01/02/2009
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged greater than or equal to 70 years, either sex
2. Office systolic blood pressure (BP) greater than 140 mmHg
3. Serum 25 Hydroxy vitamin D less than 75 nmol/L
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Hypertension known to be due to a correctable underlying medical or surgical cause
2. Diastolic blood pressure greater than 90 mmHg
3. Systolic blood pressure greater than 180 mmHg
4. Estimated glomerular filtration rate less than 40 ml/min (by four-variable modification of diet in renal disease rate [MDRD] equation)
5. Liver function tests (alanine aminotransferase [ALT], bilirubin, alkaline phosphatase) greater than 3 x normal
6. Corrected calcium greater than 2.60 mmol/L or less than 2.15 mmol/L
7. Known metastatic malignancy or sarcoidosis
8. Clinical diagnosis of osteomalacia
9. History of renal calculi
10. Diagnosis of heart failure with left ventricular systolic dysfunction
11. Atrial fibrillation
12. Already taking vitamin D supplements (consumption of fish oils will not be a contraindication to enrolment)
13. Unable to give written informed consent
Recruitment start date
01/02/2009
Recruitment end date
31/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
j.z.houston@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/470)
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23939263
Publication citations
-
Results
Witham MD, Price RJ, Struthers AD, Donnan PT, Messow CM, Ford I, McMurdo ME, Cholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial., JAMA Intern Med, 2013, 173, 18, 1672-1679, doi: 10.1001/jamainternmed.2013.9043.