The effect of oral Vitamin D supplementation on endothelial function, vascular inflammation, oxidative stress and insulin sensitivity in patients with impaired fasting glucose: A randomised, double blinded, placebo controlled trial - Vitamin D supplementation in impaired fasting glycaemia

Portsmouth Hospitals NHS Trust0 个研究点目标入组 80 人开始时间: 2015年9月2日最近更新: 2019年2月28日

试验速览

暂无简介。

•Individual with a diagnosis of impaired fasting glucose (fasting glucose 6.1-6.9 mmol/l as per WHO criteria)
•Age 18 to 75 years inclusive
•Participant is willing and able to give informed consent for participation in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease and peripheral vascular disease)
•Individuals with chronic kidney disease (stage 3B- eGFR 30-44 ml/min/1.73 m2 , stage 4- eGFR 15-29 ml/min/1.73 m2 and stage 5- eGFR <15 ml/min/1.73 m2)
•Individuals with fat malabsorption- cystic fibrosis, celiac disease, Crohn’s disease, acute or chronic pancreatitis (risk of malabsorption of Vitamin D)
•Steroids therapy (increases Vitamin D metabolism and elimination)
•On medications that can increase metabolism of vitamin D (phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampicin, non-nucleoside reverse transcriptase inhibitors used in HIV)
•Primary hyperparathyroidism
•Active granulomatous diseases including sarcoidosis and tuberculosis (increased activity of 1 alfa hydroxylase within granulomas can potentially lead to increased vitamin D toxicity)
•Allergy to vitamin D preparations, nitrates (GTN), beta2 agonists (salbutamol)
•Already taking vitamin D or calcium supplements
•On thiazide diuretics (can reduce renal excretion of calcium and increase risk of hypercalcaemia)
•On cardiac glycosides (hypercalcaemia can potentiate cardiac glycosides toxicity)
•On metformin
•Renal stones
•Peanut and soya allergy
•Pregnant and intention of becoming pregnant
•Breastfeeding
•Unable to give consent
•Participation in other clinical trials

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