None listed
Conditions
Brief summary
We invite you to participate in a research project which we believe is of potential importance in identifying the significance of vitamin D deficiency in patients with obesity and diabetes. Vitamin D deficiency has been shown to poorly affect cardiovascular health, and we hope to investigate whether vitamin D supplementation will improve markers associated with cardiovascular health. We hope that the findings of this study will help us better manage this condition in future.
Interventions
Identify patients with diabetes and obesity who have vitamin D deficiency by screening from cardiology outpatient settings (n=200). Vitamin D supplementation at 3000 international units (IU)/day or placebo orally for 3 months will be given to these patients (n=20). Cross-over between active treatment and placebo will be done for a further 3 months after a 3 month wash-out period.
Sponsors
The Queen Elizabeth Hospital, Department of Cardiology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patients with previous diagnosis of diabetes and body mass index (BMI) >=30kg/m2 with vitamin D levels <=50nmol/mL and are ambulant are enrolled
Exclusion criteria
Patients will be excluded if they are: 1. Have had treatment initiated with Angiotensin-converting enzme (ACE) inhibitors or statins in the previous 3 months 2. Have had previous adverse reaction to vitamin D supplements. 3. Previous intolerance of glyceryl trinitrate 4. Patients with severe renal impairment (calculated glomerular filtration rate (GFR) < 30mls/min) 5. Patient is pregnant
Outcome results
None listed