Contact information
Type
Scientific
Primary contact
Dr Miles Witham
ORCID ID
Contact details
Section of Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.witham@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006DM18
Study information
Scientific title
Acronym
Study hypothesis
To compare the effect of two different doses of vitamin D3 on vascular function in patients with type two diabetes.
Ethics approval
Ethics approval received from the Tayside Local Research Ethics Committee on the 10th September 2007 (ref: 07/S1401/101; Eudract: 2007-003767-51).
Study design
Double blind, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Type two diabetes mellitus
Intervention
Single dose of placebo, 100,000 units or 200,000 units of vitamin D3. Each patient will be followed-up for 16 weeks.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin D
Primary outcome measures
Change in endothelial function measured using flow-mediated dilation of the brachial artery.
Secondary outcome measures
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
Overall trial start date
01/10/2007
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Diagnosis of type two diabetes mellitus.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
90
Participant exclusion criteria
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
Recruitment start date
01/10/2007
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
11 Perth Road
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
Diabetes UK (UK) (grant ref: BDA: RD06/0003429)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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/20596692
Publication citations
-
Results
Witham MD, Dove FJ, Dryburgh M, Sugden JA, Morris AD, Struthers AD, The effect of different doses of vitamin D(3) on markers of vascular health in patients with type 2 diabetes: a randomised controlled trial., Diabetologia, 2010, 53, 10, 2112-2119, doi: 10.1007/s00125-010-1838-1.