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

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ClinicalTrials.gov Identifier: NCT02910427
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Wen-Harn Pan, Academia Sinica, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Other: Regular salt Other: Potassium-enriched salt Other: Potassium and magnesium-enriched salt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
Study Start Date : January 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sodium

Arm Intervention/treatment
Placebo Comparator: Na salt
regular salt
Other: Regular salt
Participants eat a regular salt diet.

Active Comparator: K salt
potassium-enriched salt
Other: Potassium-enriched salt
Participants eat a potassium-enriched salt diet.

Active Comparator: K/Mg salt
potassium and magnesium-enriched salt
Other: Potassium and magnesium-enriched salt
Participants eat a potassium and magnesium-enriched salt diet.




Primary Outcome Measures :
  1. The modified Rankin scale (mRs) [ Time Frame: 6 months ]
  2. The National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 6 months ]
  3. The Barthel index (BI) [ Time Frame: 6 months ]
  4. The "good neurological performance" [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910427


Sponsors and Collaborators
Academia Sinica, Taiwan
Investigators
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Principal Investigator: Wen-Harn Pan, Ph.D. Institute of Biomedical Sciences, Academia Sinica

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wen-Harn Pan, Research Fellow, Academia Sinica, Taiwan
ClinicalTrials.gov Identifier: NCT02910427     History of Changes
Other Study ID Numbers: AS-IRB-BM-08013
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Wen-Harn Pan, Academia Sinica, Taiwan:
stroke
potassium and magnesium-enriched salt
neurological performance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases