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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Regular salt Other
    Intervention Desc: Participants eat a regular salt diet.
    ARM 1: Kind: Experimental
    Label: Na salt
    Description: regular salt
  • Potassium-enriched salt Other
    Intervention Desc: Participants eat a potassium-enriched salt diet.
    ARM 1: Kind: Experimental
    Label: K salt
    Description: potassium-enriched salt
  • Potassium and magnesium-enriched salt Other
    Intervention Desc: Participants eat a potassium and magnesium-enriched salt diet.
    ARM 1: Kind: Experimental
    Label: K/Mg salt
    Description: potassium and magnesium-enriched salt

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The modified Rankin scale (mRs) 6 months No
Primary The National Institute of Health Stroke Scale (NIHSS) 6 months No
Primary The Barthel index (BI) 6 months No
Primary The "good neurological performance" 6 months No

Sponsors