Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/07/2007
Date assigned
27/09/2007
Last edited
26/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Small studies have shown that vitamin D, a hormone that the skin usually makes using sunshine, may be able to reduce blood pressure and improve blood vessel health in people with type 2 diabetes. It is not clear what the best dose of vitamin D to use is, or how long the effect of a single large dose lasts for.
The aim of the study is therefore to compare the effect of two different doses of vitamin D with placebo (dummy) and measure whether an effect on blood vessel health and blood pressure can be seen at 8 and 16 weeks after the dose.
Who can participate?
Adults aged 18 years and older with type 2 diabetes

What does the study involve?
The study lasts for 16 weeks. At the start, participants are randomly allocated to one of three groups. They receive two teaspoons of oil, which will contain either 100,000 units vitamin D3, 200,000 units vitamin D3, or a matching placebo (dummy).
Participants are assessed at the start, and 8 weeks and 16 weeks. Each visit lasts 1.5 hours.
At each visit, participants receive some or all of the following depending on which visit it is:
-Blood pressure measurement
-Blood sample taken
-Test the function of the artery in their arm. The artery is scanned with an ultrasound machine before and after inflating a blood pressure cuff on their forearm for 5 minutes. The test is repeated after the participant is given a medication (GTN) spray under their tongue
-Wear a blood pressure cuff and a heart rate monitor (ECG) for 24 hours including at home.

What are the possible benefits and risks of participating?
Although participants are unlikely to benefit directly by taking part in the trial, those who receive the vitamin D might find that blood pressure is lowered.
Although this dose of vitamin D has been used before and is known to be safe there is a small possibility of side effects. Participants are closely monitored for side effects caused by high calcium levels: sickness, diarrhoea, thirst or dizziness. To reduce the chance of vitamin D increasing the calcium level in their blood, participants are also asked not to take vitamin D supplements or calcium supplements whilst taking part in this study.
Having blood taken can cause some bruising. The blood pressure cuff causes mild discomfort to some people.

Where is the study run from?
Ninewells Hospital Dundee (UK)

When is the study starting and how long is it expected to run for?
October 2006 to January 2010
Who is funding the study?
Diabetes UK (UK)

Who is the main contact?
Dr Miles Witham (Scientific)
m.witham@dundee.ac.uk

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

2007-003767-51

ClinicalTrials.gov number

Protocol/serial number

2006DM18

Study information

Scientific title

The effect of different doses of vitamin D(3) on markers of vascular health in patients with type 2 diabetes: a randomised controlled trial

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

Tayside Local Research Ethics Committee,10/09/2007, ref: 07/S1401/101

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 measure

Change in endothelial function measured using flow-mediated dilation of the brachial artery (added 26/02/2018: at baseline, 8 and 16 weeks after vitamin D3 treatment).

Secondary outcome measures

Current secondary outcomes (as of 26/02/2018):
All measures are recorded at baseline, 8 and 16 weeks after vitamin D3 treatment.
1. Office blood pressure is measured using an oscillometric system
2. Brain Natriuretic Peptide is measured from a blood sample
3. Insulin sensitivity measured using Homeostasis Model Assessment (HOMA)
4. Parathyroid Hormone (PTH) is measured from a blood sample
5. Vitamin D levels are measured using the 25 hydroxy vitamin D test
6. Calcium levels are measured from a blood sample

Previous secondary outcomes:
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

01/10/2006

Overall trial end date

31/01/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Diagnosis of type two diabetes mellitus.

Participant type

Patient

Age group

Adult

Gender

Both

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

05/06/2008

Recruitment end date

23/10/2009

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

IPD sharing statement: The protocol is available from the authors on request but is not available online. Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained
Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk)

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

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

26/02/2018: The following changes were made: 1. Overall trial start date was changed from 01/10/2007 to 01/10/2006. 2. Recruitment start date was changed from 01/10/2007 to 05/06/2008. 3. Recruitment end date was changed from 31/03/2009 to 23/10/2009. 4. Overall trial end date was changed from 31/03/2009 to 31/10/2010. 5. Primary and secondary outcome measures were updated. 6. Participant age group, gender, participant level data, plain english summary and basic results summary were added.