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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Regular salt
* Other: Potassium-enriched salt
* Other: Potassium and magnesium-enriched salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Na salt<br>regular salt | Other: Regular salt<br>* Participants eat a regular salt diet.<br>|
| Active Comparator: K salt<br>potassium-enriched salt | Other: Potassium-enriched salt<br>* Participants eat a potassium-enriched salt diet.<br>|
| Active Comparator: K/Mg salt<br>potassium and magnesium-enriched salt | Other: Potassium and magnesium-enriched salt<br>* Participants eat a potassium and magnesium-enriched salt diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Rankin scale (mRs) |  | 6 months | 
| The National Institute of Health Stroke Scale (NIHSS) |  | 6 months | 
| The Barthel index (BI) |  | 6 months | 
| The good neurological performance | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, potassium and magnesium-enriched salt, neurological performance