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

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, potassium and magnesium-enriched salt, neurological performance
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.
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
NCT ID
NCT02910427
First Posted
September 9, 2016
Last Updated
September 20, 2016
Sponsor
Academia Sinica, Taiwan
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
Learn more about this trial
The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
We'll reach out to this number within 24 hrs