Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of type 2 diabetes mellitus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Taking vitamin D supplements - Serum 25 hydroxy vitamin D level of >100nmolL - Serum creatinine >200umol/l - Liver function tests >3 times the upper limit of normal - Hyper or hypocalcaemia (corrected calcium >2.55 or <2.15mmol/l, respectively) - History of sarcoidosis - History of renal calculi - Metastatic malignancy - Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether higher doses of vitamin D3 improve blood pressure and vascular function more than lower doses of vitamin D3;Secondary Objective: To test whether patients with normal baseline vitamin D levels benefit from supplementation as much as those with low baseline vitamin D levels To test whether patients receiving supplementation in summer benefit as much as those receiving supplementation in winter;Primary end point(s): Change in endothelial function as measured by flow mediated dilatation of the brachial artery | — |
Countries
United Kingdom