Preventing/ delaying the onset of type 2 diabetes mellitus and cardiovascular risk factors. MedDRA version: 10.0 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Vigantol Oil
Product Name: Cholecalciferol (vitamin D3)
Pharmaceutical Form: Oral drops*
INN or Proposed INN: Cholecalciferol
Sponsors
Queen Mary University of London
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1 Inclusion 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 Or 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. Or 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 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: 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) 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) • Known active sarcoidosis, tuberculosis or malignancy (GP records, participant history) • Taking cardiac glycosides, thiazide diuretics or corticosteroids in the past one month (GP records, participant history) • Documented anaemia of <11g% or known haemoglobinopathy such as sickle cell anaemia and beta or alpha thalassemia (GP records, participant history) • Planned travel out of the London area or Cambridge (depending of site of recruitment) within 8 weeks of enrolment such that it will disrupt monitoring of the participant (Participant history) • Breast feeding, pregnancy or planning a pregnancy (Participant history) NB – 1. Women of childbearing potential and men must be willing to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) from the time consent is signed until 6 weeks after the end of treatment. 2. Women of childbearing potential must have a negative pregnancy test result within 7 days prior to being registered for the protocol therapy. (NOTE: Subjects are considered not of child bearing potential only if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or if they are postmenopausal). 3. Women must not be breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of this study is to determine whether a monthly dose of 100,000 IU of vitamin D2 or D3 (the two forms of vitamin D currently available in the market) can lead to a reduction in sugar levels (glycaemia as measured by HbA1c) in people at high risk of developing diabetes. ; Secondary Objective: To determine whether • vitamin D at the proposed dose is safe and well-tolerated by trial participants. • vitamin D2 or vitamin D3 are equally potent or whether there is a biological advantage of one over the other. • vitamin D supplementation improves risk factors associated with cardiovascular disease and strokes. • the feasibility and acceptability of high dose vitamin D supplementation to inform a future trial with diabetes and/or cardiovascular endpoints. ;Primary end point(s): Glycaemia as assessed by HbA1c at the final visit | — |
Countries
United Kingdom
Outcome results
None listed