Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dundee.ac.uk/

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

  1. 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.

Editorial Notes