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临床试验/ISRCTN35648481
ISRCTN35648481已完成未知

Optimising Vitamin D Status in Older People: A Randomised Controlled Trial of Vitamin D Supplementation

ewcastle Joint Research Office0 个研究点目标入组 379 人开始时间: 2012年8月16日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
379

研究概览

简要总结

  1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041337 2. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30624670 [added 10/01/2019]

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Inclusion criteria as of 07/04/2017:
  • 1. Ambulant, community dwelling men and women aged 70 years and above (by end April2013)
  • 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
  • Original inclusion criteria:
  • 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
  • 4. Male and female participants
  • 5. > 70 years old

排除标准

  • Exclusion criteria as of 07/04/2017:
  • 1. Current antiresorptive or anabolic treatment for osteoporosis
  • 2. Treatment with bisphosphonates for osteoporosis in past two years
  • 3. Current supplement 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 hyperparathyroidism
  • 6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l)
  • 7. Renal impairment (Stage 4-5 Chronic Kidney Disease: eGFR < 30 ml/min/1.73m2)
  • 8. History of renal stones
  • Original exclusion criteria:
  • 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

研究者

发起方
ewcastle Joint Research Office

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