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ISRCTN
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ISRCTN50587697
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ClinicalTrials.gov identifier
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Public title
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Vitamin D therapy to reduce cardiovascular risk in type two diabetes - the next steps
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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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2006DM18
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Study hypothesis
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To compare the effect of two different doses of vitamin D3 on vascular function in patients with type two diabetes.
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Ethics approval
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Ethics approval received from the Tayside Local Research Ethics Committee on the 10th September 2007 (ref: 07/S1401/101; Eudract: 2007-003767-51).
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Study design
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Double blind, 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 two diabetes mellitus
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Participants - inclusion criteria
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Diagnosis of type two diabetes mellitus.
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Participants - exclusion criteria
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1. Taking vitamin D supplements
2. Serum 25 hydroxy vitamin D level of greater than 100 nmol/L
3. Serum creatinine greater than 200 umol/l
4. Liver function tests greater than three times the upper limit of normal
5. Hyper- or hypo-calcaemia (corrected calcium greater than 2.55 or less than 2.15 mmol/l, respectively)
6. Metastatic malignancy
7. Inability to give informed consent
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Anticipated start date
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01/10/2007
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Anticipated end date
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31/03/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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90
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Interventions
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Single dose of placebo, 100,000 units or 200,000 units of vitamin D3. Each patient will be followed-up for 16 weeks.
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Primary outcome measure(s)
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Change in endothelial function measured using flow-mediated dilation of the brachial artery.
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Secondary outcome measure(s)
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Change in:
1. Office and 24-hour Blood Pressure (BP)
2. Brain Natriuretic Peptide (BNP)
3. Heart rate variability
4. Insulin sensitivity (Homeostasis Model Assessment [HOMA])
5. Angiotensin II, renin, aldosterone
6. Parathyroid Hormone (PTH) and 25 hydroxy vitamin D levels
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Sources of funding
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Diabetes UK (UK) (grant ref: BDA: RD06/0003429)
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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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Section of Ageing and Health
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 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
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 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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Sponsor website:
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http://www.dundee.ac.uk/
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Date applied
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11/07/2007
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Last edited
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28/09/2007
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Date ISRCTN assigned
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27/09/2007
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