Optimising Vitamin D Status in Older People: A Randomised Controlled Trial of Vitamin D Supplementation - Optimising Vitamin D Status in Older People (VDOP)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 379 人开始时间: 2012年7月10日最近更新: 2019年6月30日

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•1. Ambulant, community dwelling men and women aged 70 years and above 2. Individuals capable of giving informed consent on their own behalf 3. Individuals willing to attend the Study Centre (CARU) on six occasions and to be contacted by telephone at monthly intervals between study visits over twelve months The inclusion criteria are mainly restricted to age and ability to participate in the study. The age cut-off used is the same as the threshold for older age used in the most recently published review and recommendations
•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 375

•1. Current antiresorptive or anabolic treatment for osteoporosis 2. Treatment with bisphosphonates for osteoporosis in past two years 3. Current use of vitamin D (>400 IU/day) or calcium (>500 mg/day) (including use of over-the-counter preparations) 4. Fragility fracture in the previous six months 5. Known primary hyperparathyroisism 6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l) 7. Renal impairment (Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2) 8. History of renal stones 9. Peanut allergy The exclusion criteria include the presence of a health condition or treatment which is likely to independently affect the outcome measures (criteria: 1, 2, 3, 4, 5, 8) or increase the risk of developing adverse effects with vitamin D supplementation (criteria: 6, 9).

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust