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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02910427
Enrollment
291
Registered
2016-09-22
Start date
2009-01-31
Completion date
2014-12-31
Last updated
2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, potassium and magnesium-enriched salt, neurological performance

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.

Interventions

Participants eat a regular salt diet.

OTHERPotassium-enriched salt

Participants eat a potassium-enriched salt diet.

OTHERPotassium and magnesium-enriched salt

Participants eat a potassium and magnesium-enriched salt diet.

Sponsors

Academia Sinica, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 performance6 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026