Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/07/2005
Date assigned
12/09/2005
Last edited
04/01/2011
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 Justine Davies

ORCID ID

Contact details

Dept of Clinical Pharmacology
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632180
j.i.davies@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

JUS004

Study information

Scientific title

Acronym

Study hypothesis

That Vitamin D improves endothelial function, pulse wave velocity, insulin sensitivity and markers of renin-angiotensin system activation in type 2 diabetics

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes mellitus

Intervention

100,000 units ergocalciferol versus placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin D, ergocalciferol

Primary outcome measures

Change in flow mediated dilatation of the brachial artery

Secondary outcome measures

Pulse wave velocity, homeostasis model assessment (HOMA) index, renin, angiotensin, Vitamin D, parathyroid hormone (PTH)

Overall trial start date

01/10/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥18 years
2. Vitamin D level <50 nmol/l

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

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

Recruitment start date

01/10/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344664
j.z.houston@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Diabetes UK (no ref no. allocated at present)

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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18279409

Publication citations

  1. Results

    Sugden JA, Davies JI, Witham MD, Morris AD, Struthers AD, Vitamin D improves endothelial function in patients with Type 2 diabetes mellitus and low vitamin D levels., Diabet. Med., 2008, 25, 3, 320-325, doi: 10.1111/j.1464-5491.2007.02360.x.

Additional files

Editorial Notes