A randomized, double blind, placebo controlled, phase II, multi-centre pilot study to investigate the effects of vitamin D2 or D3 supplementation on metabolic parameters in people at risk of type 2 diabetes. - Vitamin D Supplementation in People at Risk of Type 2 Diabetes V1.3

Queen Mary University of London0 sites340 target enrollmentNovember 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 9, 2009

End Date

November 28, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•4\.1Inclusion Criteria
•a) Number of participants: 342 (divided between Cambridge and East London, see sample size calculations in appendix)
•b) Age 30\-75yrs.
•c) All ethnic groups
•d) People at risk of developing T2D as defined by:
•The Cambridge Risk Score (CRS) \[80\-82]. The CRS cut\-offs would be 0\.236 for the Black/Caribbean population, 0\.127 for South Asians and 0\.199 for Caucasians \[83]. For other groups the cut\-off for Caucasians will be used
•Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) defined by current WHO criteria, where this information is available in medical records, or in the records of studies in which participants have consented to being re\-approached to consider taking part in future studies.
•Non\-diabetic hyperglycaemia (defined as HbA1c from 5\.5% to 6\.49%), where this information is available in medical records, or in the records of studies in which participants have consented to being re\-approached to consider taking part in future studies.
•e) Can provide informed consent for participation in the trial.
•Are the trial subjects under 18? no

•Exclusion Criteria
•Known T2D or use of oral hypoglycaemic agents (GP records, participant history)
•Random blood glucose during initial screening \>11 mmol/l (Screening)
•Known intolerance to vitamin D2 or D3 (GP records, participant history)
•Currently taking vitamin D supplements (GP records, participant history)
•Prior history of hypercalcaemia (serum calcium \>2\.65 mmol/l) (GP records, participant history)or point of care ionised calcium \>1\.3mmol/l. (Screening)
•Stage 4 or worse chronic kidney disease (eGFR (estimated glomerular filtration rate) \< 30 ml/min) (GP records, participant history)
•History of significant liver disease (AST (aspartate aminotransferase) \>3 x upper limit of normal (ULN) or serum bilirubin \> 2\.5 x ULN) (GP records, participant history)
•Past or current history of renal stones (GP records, participant history)
•Known hyperparathyroidism (GP records, participant history)