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临床试验/NCT04395638
NCT04395638暂停不适用

Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland

University of Ulster1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
1
主要终点
Vitamin D status

研究概览

简要总结

The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health & Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status <30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.

排除标准

  • Participants will be excluded from the study if by the judgement of the consultant rheumatologist that they have very abnormal bone or vitamin D metabolism due to conditions such as end stage renal failure or bone metastases.

结局指标

主要结局

Vitamin D status

时间窗: Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention

Plasma 25(OH)D status analysis by Liquid Chromatography / Mass Spec (LC/MS)

次要结局

  • Bone-specific alkaline phosphatase concentration(Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention)
  • Osteocalcin concentration(Change between baseline (week 0 pre-intervention) and weeks 2, 4, 8 post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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