The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
Completed
Phase N/A Results N/ATrial 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
Recruitment
- Enrollment: 291
- Gender: Both
- Minimum Age: 45 Years
- Accepts Healthy Volunteers: No
Principal Investigator
- Wen-Harn Pan, Ph.D.
Institute of Biomedical Sciences, Academia Sinica