Feasibility study including a double blind (C)controlled study and an open label (C) controlled study for a larger randomised trial measuring the effect of oral vitamin D (I) on morbidity and mortality (O) in men and women aged 65-84 (P) - Vitamin D and Longevity (VIDAL) Trial: randomised feasibility study v1

ondon School of Hygiene & Tropical Medicine0 个研究点目标入组 11,376 人开始时间: 2012年2月14日最近更新: 2019年4月30日

适应症

试验速览

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•Age = 65 years and = 84 years at enrolment • Contactable by telephone, able to receive postal recorded deliveries, and able to attend enrolment at the GP surgery • GP notes for the previous year are available
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1600

•Known active tuberculosis, sarcoidosis, hyperparathyroidism, past or present nephrolithiasis, vitamin D intolerance, referral for suspected hepatic or renal dysfunction, terminal illness, any malignancy other than non-melanoma skin cancer not in remission for = 3 years • Planning to move from the GP practice or to emigrate within 5 years • Any other condition that in the PI’s or CI’s judgement might compromise participant safety or compliance, interfere with evaluation or preclude completion of the study. • Baseline corrected serum calcium > 2.65 mmol/L • Taking dietary supplement or other medication containing >400 IU (10 micrograms) per day vitamin D • Treatment with any other investigational medical product or device up to 4 months before first dose of IMP • Concomitant therapy with any of the following: carbamazepine, phenobarbital, phenytoin, primidone, digoxin, oral 1-alpha-hydroxylated vitamin D preparations (e.g. alfalcalcidol, calcitriol) or the combination of a thiazide diuretic (e.g. bendrofluazide, metolazone) with a calcium supplement

发起方

ondon School of Hygiene & Tropical Medicine