Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/07/2007
Date assigned
27/09/2007
Last edited
02/02/2011
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 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

http://www.dundee.ac.uk/

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

  1. 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.

Additional files

Editorial Notes