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ISRCTN
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ISRCTN46424296
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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 type 2 diabetes?
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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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JUS004
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Study hypothesis
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That Vitamin D improves endothelial function, pulse wave velocity, insulin sensitivity and markers of renin-angiotensin system activation in type 2 diabetics
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised 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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Type 2 diabetes mellitus
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Participants - inclusion criteria
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1. Age ≥18 years
2. Vitamin D level <50 nmol/l
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Participants - exclusion criteria
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1. Serum creatinine >200 µmol/l
2. Liver function tests >3 x upper limit of normal
3. Corrected calcium >2.55 mmol/l or <2.15 mmol/l
4. Metastatic malignancy
5. Unable to give informed consent
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/06/2006
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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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60
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Interventions
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100,000 units ergocalciferol versus placebo
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Primary outcome measure(s)
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Change in flow mediated dilatation of the brachial artery
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Secondary outcome measure(s)
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Pulse wave velocity, homeostasis model assessment (HOMA) index, renin, angiotensin, Vitamin D, parathyroid hormone (PTH)
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Sources of funding
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Diabetes UK (no ref no. allocated at present)
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Trial website
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18279409
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Contact name
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Dr
Justine
Davies
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Address
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Dept of Clinical Pharmacology
Ninewells Hospital
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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 632180
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Fax
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+44 (0)1382 644972
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Email
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j.i.davies@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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11 Perth Road
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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 344664
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Fax
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+44 (0)1382 202178
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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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26/07/2005
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Last edited
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04/01/2011
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Date ISRCTN assigned
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12/09/2005
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