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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Na salt | Placebo Comparator | regular salt |
|
| K salt | Active Comparator | potassium-enriched salt |
|
| K/Mg salt | Active Comparator | potassium and magnesium-enriched salt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular salt | Other | Participants eat a regular salt diet. |
| |
| Potassium-enriched salt |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Harn Pan, Ph.D. | Institute of Biomedical Sciences, Academia Sinica | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28877896 | Derived | Pan WH, Lai YH, Yeh WT, Chen JR, Jeng JS, Bai CH, Lin RT, Lee TH, Chang KC, Lin HJ, Hsiao CF, Chern CM, Lien LM, Liu CH, Chen WH, Chang A. Intake of potassium- and magnesium-enriched salt improves functional outcome after stroke: a randomized, multicenter, double-blind controlled trial. Am J Clin Nutr. 2017 Nov;106(5):1267-1273. doi: 10.3945/ajcn.116.148536. Epub 2017 Sep 6. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011188 | Potassium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Other |
Participants eat a potassium-enriched salt diet. |
|
| Potassium and magnesium-enriched salt | Other | Participants eat a potassium and magnesium-enriched salt diet. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008670 |
| Metals |