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
- 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
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