| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN50587697 |
| Date ISRCTN assigned | 27/09/2007 |
| Local reference number(s) | 2006DM18 |
| Public title | Vitamin D therapy to reduce cardiovascular risk in type two diabetes - the next steps |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Type two diabetes mellitus |
| Study hypothesis | To compare the effect of two different doses of vitamin D3 on vascular function in patients with type two diabetes. |
| Design/methodology | Double blind, randomised controlled trial |
| Research ethics review | Ethics approval received from the Tayside Local Research Ethics Committee on the 10th September 2007 (ref: 07/S1401/101; Eudract: 2007-003767-51). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Diagnosis of type two diabetes mellitus. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 31/03/2009 |
| Status of trial | Ongoing |
| Target number of participants | 90 |
| Interventions | Single dose of placebo, 100,000 units or 200,000 units of vitamin D3. Each patient will be followed-up for 16 weeks. |
| Primary outcome measure(s) | Change in endothelial function measured using flow-mediated dilation of the brachial artery. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Diabetes UK (UK) (grant ref: BDA: RD06/0003429) |
| Sponsor name | University of Dundee (UK) |
| Sponsor details | Research and Innovation Services
11 Perth Road
Dundee
United Kingdom
DD1 4HN |
| Sponsor telephone | +44 (0)1382 384664 |
| Sponsor fax | +44 (0)1382 386765 |
| Sponsor email | j.z.houston@dundee.ac.uk |
| Sponsor website | http://www.dundee.ac.uk/ |
| Contact name | Dr Miles Witham |
| Contact details | Section of Ageing and Health
Ninewells Hospital
Dundee
United Kingdom
DD1 9SY |
| Contact telephone | +44 (0)1382 632436 |
| Contact fax | +44 (0)1382 660675 |
| Contact email | m.witham@dundee.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN50587697 |
| Date last extracted from ISRCTN register | 17/04/2008 |
