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临床试验/NCT02910427
NCT02910427已完成不适用

The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients

Academia Sinica, Taiwan0 个研究点目标入组 291 人开始时间: 2009年1月1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
291
主要终点
The modified Rankin scale (mRs)

研究概览

简要总结

Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of life and neurological deficits remains extraordinary. Stroke incidence and mortality are also rising in the developed countries presumably due to a world-wide increase in prevalence of obesity and metabolic syndrome. Negative associations have been observed between high blood pressure, hyperglycemia and two major dietary cations in vegetables and dairy products: potassium and magnesium. Mean levels of dietary potassium and magnesium intake in Taiwan are much lower than those of dietary reference intake. Short term supplementation studies have demonstrated their effects in reducing blood pressure and degree of insulin resistance. However, long-term studies on cardiovascular events are lacking. Our previous long-term intervention trial in elderly veteran home showed a 41% reduction in cardiovascular mortality by simply switching regular cooking salt to potassium-enriched salt in kitchens. The investigators have previously observed an annual reduction of medical cost around $ 15,000 NT in the aforementioned veteran home trial. A multi-centered randomized controlled trial was carried out with three arms: (1) regular salt (Na salt), (2) potassium-enriched salt (K salt), and (3) potassium and magnesium-enriched salt (K/Mg salt). The objectives of this study was to investigate whether potassium and magnesium-enriched salt would improve the neurological performance of the stroke patients.The investigators anticipate to observe beneficial effect from consuming potassium and magnesium enriched salt for neurological improvement in stroke patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • hospitalization within 1 month due to cerebral infarction or hemorrhage;
  • a modified Rankin Score of 4 or less at the time of discharge;
  • an age of 45 or older; and
  • an agreement to prepare foods with salt provided by the project.

排除标准

  • patients with poor kidney function (glomerular filtration rate<60 ml/min), secondary hypertension, cancer, or liver diseases;
  • patients with eating disorders;
  • patients taking K-sparing medicines;
  • or patients using salt substitutes.

结局指标

主要结局

The modified Rankin scale (mRs)

时间窗: 6 months

The Barthel index (BI)

时间窗: 6 months

The National Institute of Health Stroke Scale (NIHSS)

时间窗: 6 months

The "good neurological performance"

时间窗: 6 months

The "good neurological performance" is defined as those who met all of the following criteria: a score of zero in NIHSS, a score of 100 in BI, and a score of equal to or less than 1 in mRS.

次要结局

未报告次要终点

研究者

发起方
Academia Sinica, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Harn Pan

Research Fellow

Academia Sinica, Taiwan

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