Condition category
Circulatory System
Date applied
21/02/2007
Date assigned
01/05/2007
Last edited
29/03/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miles Witham

ORCID ID

Contact details

Department of Medicine & Therapeutics
University of Dundee
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.witham@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Res/A107

Study information

Scientific title

Acronym

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stroke

Intervention

A single oral dose of 100,000 U ergocalciferol (vitamin D) or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/06/2007

Overall trial end date

30/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical diagnosis of completed stroke (ischaemic or haemorrhagic)
2. Serum 25-hydroxy vitamin D level less than 50 nmol/L

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

68 (two groups of 34)

Participant 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)

Recruitment start date

01/06/2007

Recruitment end date

30/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine & Therapeutics
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
j.z.houston@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Chest Heart and Stroke Scotland (UK)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21194910

Publication citations

  1. Results

    Witham MD, Dove FJ, Sugden JA, Doney AS, Struthers AD, The effect of vitamin D replacement on markers of vascular health in stroke patients - a randomised controlled trial., Nutr Metab Cardiovasc Dis, 2012, 22, 10, 864-870, doi: 10.1016/j.numecd.2010.11.001.

Additional files

Editorial Notes