Trial | NCT02910427  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    291
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.
Study Started
Jan 31
2009
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Sep 22
2016
Estimate

Other Regular salt

Participants eat a regular salt diet.

Other Potassium-enriched salt

Participants eat a potassium-enriched salt diet.

Other Potassium and magnesium-enriched salt

Participants eat a potassium and magnesium-enriched salt diet.

Na salt Placebo Comparator

regular salt

K salt Active Comparator

potassium-enriched salt

K/Mg salt Active Comparator

potassium and magnesium-enriched salt

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.
No Results Posted