|
ISRCTN
|
ISRCTN28737567
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does vitamin D improve markers of vascular health in stroke patients?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
Res/A107
|
|
Study hypothesis
|
That a single dose of oral vitamin D can lower blood pressure and improve endothelial function in stroke patients
|
|
Ethics approval
|
Ethics approval received from the Tayside Local Research Ethics Committee on the 14th May 2007 (ref: 07/S1401/41).
|
|
Study design
|
Double blind, randomised, placebo controlled trial.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Stroke
|
|
Participants - inclusion criteria
|
1. Clinical diagnosis of completed stroke (ischaemic or haemorrhagic)
2. Serum 25-hydroxy vitamin D level less than 50 nmol/L
|
|
Participants - exclusion criteria
|
1. Hyper- or hypocalcaemia
2. Metastatic malignancy
3. Liver function tests over three times limit of normal
4. Estimated glomerular filtration rate (GFR) less than 40 ml/min
5. Previous clinical diagnosis of osteomalacia
6. Taking vitamin D preparations
7. Unable to give written informed consent
8. Unable to swallow tablets orally
9. Atrial fibrilation (to provide a more homogeneous aetiology)
|
|
Anticipated start date
|
01/06/2007
|
|
Anticipated end date
|
30/11/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
68 (two groups of 34)
|
|
Interventions
|
A single oral dose of 100,000 U ergocalciferol (vitamin D) or placebo.
|
|
Primary outcome measure(s)
|
Blood pressure (seated office and 24 hour measurements) will be measured at baseline and then at 8 and 16 weeks after vitamin D administration.
|
|
Secondary outcome measure(s)
|
The secondary outcomes will also be measured at baseline and then at 8 and 16 weeks after vitamin D administration.
1. Endothelial function
2. B-type natriuretic peptide
3. Heart rate variability
|
|
Sources of funding
|
Chest Heart and Stroke Scotland (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Miles
Witham
|
|
Address
|
Department of Medicine & Therapeutics
University of Dundee
Ninewells Hospital & Medical School
|
|
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
|
|
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
|
|
Date applied
|
21/02/2007
|
|
Last edited
|
28/04/2008
|
|
Date ISRCTN assigned
|
01/05/2007
|
