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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Regular salt
Potassium-enriched salt
Potassium and magnesium-enriched salt
Sponsored by
Academia Sinica, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, potassium and magnesium-enriched salt, neurological performance

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Na salt

    K salt

    K/Mg salt

    Arm Description

    regular salt

    potassium-enriched salt

    potassium and magnesium-enriched salt

    Outcomes

    Primary Outcome Measures

    The modified Rankin scale (mRs)
    The National Institute of Health Stroke Scale (NIHSS)
    The Barthel index (BI)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2016
    Last Updated
    September 20, 2016
    Sponsor
    Academia Sinica, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02910427
    Brief Title
    The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
    Official Title
    The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academia Sinica, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, potassium and magnesium-enriched salt, neurological performance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    291 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Na salt
    Arm Type
    Placebo Comparator
    Arm Description
    regular salt
    Arm Title
    K salt
    Arm Type
    Active Comparator
    Arm Description
    potassium-enriched salt
    Arm Title
    K/Mg salt
    Arm Type
    Active Comparator
    Arm Description
    potassium and magnesium-enriched salt
    Intervention Type
    Other
    Intervention Name(s)
    Regular salt
    Intervention Description
    Participants eat a regular salt diet.
    Intervention Type
    Other
    Intervention Name(s)
    Potassium-enriched salt
    Intervention Description
    Participants eat a potassium-enriched salt diet.
    Intervention Type
    Other
    Intervention Name(s)
    Potassium and magnesium-enriched salt
    Intervention Description
    Participants eat a potassium and magnesium-enriched salt diet.
    Primary Outcome Measure Information:
    Title
    The modified Rankin scale (mRs)
    Time Frame
    6 months
    Title
    The National Institute of Health Stroke Scale (NIHSS)
    Time Frame
    6 months
    Title
    The Barthel index (BI)
    Time Frame
    6 months
    Title
    The "good neurological performance"
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Harn Pan, Ph.D.
    Organizational Affiliation
    Institute of Biomedical Sciences, Academia Sinica
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28877896
    Citation
    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.
    Results Reference
    derived

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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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