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临床试验/NCT04956705
NCT04956705已完成不适用

Vitamin D and Calcium Supplementation at Danish Nursing Homes - Effects on Vitamin D Status and Physical Functioning

University College Copenhagen4 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
4
主要终点
Number of residents having vitamin D and calcium supplements daily

研究概览

简要总结

Nursing home residents are in high risk of vitamin D deficiency, which negatively affects bone health. Vitamin D and calcium supplements have shown to increase bone density and reduce fracture risk and may affect daily physical functioning. Therefore, The Danish Health Authority recommends all nursing home residents a daily supplement of 20 µg vitamin D and 800-1000 mg calcium. However, adherence to the recommendation is low.

The present project hypothesizes that this low adherence results in a high number of residents with a deficient or insufficient vitamin D status, and that daily physical functioning can be improved or maintained by an improved adherence to the recommendation.

详细描述

Background: Residents in nursing homes belong to one of the high-risk groups when it comes to vitamin D deficiency, which is associated with increased risk of osteoporosis, muscle weakness and generally decreased physical functioning and frailty. Therefore, the Danish Health Authority recommends that all residents in nursing homes receive a daily supplement of 20 µg of vitamin D in addition to 800-1000 mg of calcium. Some systematic reviews and meta-analyses find that daily supplementation of 20 µg of vitamin D can improve physical functioning and muscle strength among older adults, whereas others do not find an effect. However, most studies are performed in non-institutionalized older adults.

An online survey conducted in May 2020 has revealed that the recommendation of giving residents in nursing homes a daily supplement of 20 µg vitamin D and 800-1000 mg calcium is not routine clinical practice in Denmark. The Danish Health Authority highlights The Model for Improvement as a tool to use when working with evidence-based practice within prevention and health promotion in the municipalities.

Objectives:

  • To increase use of the recommended supplements with vitamin D and calcium among residents at nursing homes using The Model for Improvement as a methodological tool.
  • To investigate the effect of improved vitamin D and calcium supplement use on vitamin D status and daily physical functioning among residents at nursing homes.

Hypotheses:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a resident at the participating nursing homes
  • Understand and speak Danish in order to understand the study procedures
  • Be able to give informed consent

排除标准

  • Having kidney diseases
  • Receiving medication which may induce adverse effects in combination with vitamin D and/or calcium supplements
  • Being terminally ill
  • Declared incompetent

结局指标

主要结局

Number of residents having vitamin D and calcium supplements daily

时间窗: 6 months

Assessed as those having ≥ 20 µg vitamin D and/or ≥ 800 mg calcium ≥ 5 days /week

次要结局

  • Vitamin D status(6 months)
  • Handgrip strength(6 months)
  • Physical functioning(6 months)

研究者

发起方
University College Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Mortensen

Principal Investigator

University College Copenhagen

研究点 (4)

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