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ISRCTN
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ISRCTN28737567
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ClinicalTrials.gov identifier
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Public title
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Does vitamin D improve markers of vascular health in stroke patients?
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Scientific title
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Acronym
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N/A
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Serial number at source
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Res/A107
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Study hypothesis
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That a single dose of oral vitamin D can lower blood pressure and improve endothelial function in stroke patients
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Lay summary
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Ethics approval
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Ethics approval received from the Tayside Local Research Ethics Committee on the 14th May 2007 (ref: 07/S1401/41).
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Study design
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Double blind, randomised, placebo controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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1. Clinical diagnosis of completed stroke (ischaemic or haemorrhagic)
2. Serum 25-hydroxy vitamin D level less than 50 nmol/L
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/06/2007
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Anticipated end date
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30/11/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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68 (two groups of 34)
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Interventions
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A single oral dose of 100,000 U ergocalciferol (vitamin D) or placebo.
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Primary outcome measure(s)
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Blood pressure (seated office and 24 hour measurements) will be measured at baseline and then at 8 and 16 weeks after vitamin D administration.
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Secondary outcome measure(s)
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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
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Sources of funding
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Chest Heart and Stroke Scotland (UK)
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Trial website
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Publications
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Contact name
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Dr
Miles
Witham
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Address
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Department of Medicine & Therapeutics
University of Dundee
Ninewells Hospital & Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 632436
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Fax
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+44 (0)1382 660675
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Email
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m.witham@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Research and Innovation Services
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Tel
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+44 (0)1382 384664
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Fax
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+44 (0)1382 386765
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Email
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j.z.houston@dundee.ac.uk
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Date applied
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21/02/2007
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Last edited
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28/04/2008
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Date ISRCTN assigned
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01/05/2007
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