EUCTR2012-001249-41-DE进行中（未招募）不适用
Vitamin D3 – Omega3 – Home Exercise – HeALTHy Ageing and LongevityTrial Randomized, double-blind, placebo-controlled, multi-centre clinicaltrial - DO – HEALTH
niversity Hospital of Zurich and City Hospital Waid0 个研究点目标入组 2,152 人开始时间: 2012年10月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Mini Mental State Examination Score of at least 24
- •- Living in the community
- •- Sufficiently mobile to come to the study centre, to walk 10 meters with or without walking aid and to get in and out of a chair without help
- •- Able to swallow study medication
- •- Able and willing to participate, sign informed consent (including
- •consent to analyze all samples until withdrawal) and cooperate with
- •study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2152
排除标准
- •(1) Consumption of more than 1000 IU vitamin D/day in the 6 month prior to enrolment, and/or a bolus of 300'000 IU vitamin D or more in the 12 month prior to enrolment, and /or unwillingness to limit vitamin D intake to the current standard of 800 IU/day of vitamin D during the course of the trial
- •(2) Unwillingness to limit calcium supplement dose to 500 mg per day for the duration of the trial
- •(3) Taking omega-3 fat supplements and unwilling to forgo their use for the duration of the trial
- •(4) Use of any active vitamin D metabolite (i.e. Rocaltrol,
- •alphacalcidiol), PTH treatment (i.e. Teriparatide), or Calcitonin at
- •baseline and unwillingness to forego these treatments during the
- •course of the trial
- •(5) Current or recent (previous 4 months) participation in another clinical trial, or plans of such participation in the next 3 years (corresponding to DO-HEALTH length)
- •(6) Presence of the following diagnosed health conditions in the last 5 years: history of cancer (except non-melanoma skin cancer); myocardial infarction, stroke, transient ischemic attack, angina pectoris, or coronary artery intervention
- •(7) Severe renal impairment (creatinine clearance = 15 ml/min) or
- •dialysis, hypercalcaemia (> 2.6 mmol/l)
- •(8) Hemiplegia or other severe gait impairment
- •(9) History of hypo- or primary hyper-parathyroidism
- •(10) Severe liver disease
- •(11) History of granulomatous diseases (i.e. tubercolosis, sarcoidosis)
- •(12) Major visual or hearing impairment or other serious illness that would preclude participation
- •(13) Living with a partner who is enrolled in DO-HEALTH (we exclude couples)
- •(14) Living in assisted living situations or a nursing home
- •(15) Temporary exclusion: acute fracture in the last 6 weeks
- •(16) Epilepsy and/or use of anti-epileptic drugs
- •(17) Individuals who fell more than 3 times in the last month
- •(18) Osteodystrophia deformans (M. Paget, Paget's disease)
研究者
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