| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN28737567 |
| Date ISRCTN assigned | 01/05/2007 |
| Local reference number(s) | Res/A107 |
| Public title | Does vitamin D improve markers of vascular health in stroke patients? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Stroke |
| Study hypothesis | That a single dose of oral vitamin D can lower blood pressure and improve endothelial function in stroke patients |
| Design/methodology | Double blind, randomised, placebo controlled trial. |
| Research ethics review | Pending as of 21 February 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Clinical diagnosis of completed stroke (ischaemic or haemorrhagic)
2. Serum 25-hydroxy vitamin D level <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) <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) |
| Patient information material |
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| Anticipated start date | 01/06/2007 |
| Anticipated end date | 30/11/2008 |
| Status of trial | Ongoing |
| 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) |
| Sponsor name | University of Dundee (UK) |
| Sponsor details | Research and Innovation Services
Dundee
United Kingdom
DD1 4HN |
| Sponsor telephone | +44 (0)1382 384664 |
| Sponsor fax | +44 (0)1382 386765 |
| Sponsor email | j.z.houston@dundee.ac.uk |
| Contact name | Dr Miles Witham |
| Contact details | Department of Medicine & Therapeutics
University of Dundee
Ninewells Hospital & Medical School
Dundee
United Kingdom
DD1 9SY |
| Contact telephone | +44 (0)1382 632436 |
| Contact fax | +44 (0)1382 660675 |
| Contact email | m.witham@dundee.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN28737567 |
| Date last extracted from ISRCTN register | 17/04/2008 |
