EUCTR2009-011264-11-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •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
排除标准
- •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)
- •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.
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