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Vitamin D for Isolated Systolic Hypertension (VitDISH)
ISRCTN ISRCTN92186858
DOI 10.1186/ISRCTN92186858
ClinicalTrials.gov identifier
EudraCT number
Public title Vitamin D for Isolated Systolic Hypertension (VitDISH)
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
Serial number at source 2007CV09
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Isolated systolic hypertension
Participants - 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
Participants - 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
Anticipated start date 01/02/2009
Anticipated end date 31/01/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions 100,000 units of vitamin D3 or placebo every 3 months for 1 year.
Primary outcome measure(s) Change in office blood pressure at 3 months.
Secondary outcome measure(s) 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
Sources of funding Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/470)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23939263
Contact name Dr  Miles  Witham
  Address Section of Ageing and Health
Ninewells Hospital
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
  Tel +44 (0)1382 632436
  Fax +44 (0)1382 660675
  Email m.witham@dundee.ac.uk
Sponsor University of Dundee (UK)
  Address Research and Innovation Services
11 Perth Road
  City/town Dundee
  Zip/Postcode DD1 4HN
  Country United Kingdom
  Tel +44 (0)1382 384664
  Fax +44 (0)1382 386765
  Email j.z.houston@dundee.ac.uk
  Sponsor website: http://www.dundee.ac.uk/
Date applied 01/07/2008
Last edited 14/08/2013
Date ISRCTN assigned 21/08/2008
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