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

Academia Sinica, Taiwan

Status: Completed

Conditions: Stroke

Treatments: Other: Potassium-enriched salt; Other: Regular salt; Other: Potassium and magnesium-enriched salt

Study type: Interventional

Funder types: Other

Identifiers

NCT02910427

AS-IRB-BM-08013

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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291 participants in 3 patient groups, including a placebo group

Na salt

Placebo Comparator group

Description:

regular salt

Treatment:

Other: Regular salt

K salt

Active Comparator group

Description:

potassium-enriched salt

Treatment:

Other: Potassium-enriched salt

K/Mg salt

Active Comparator group

Description:

potassium and magnesium-enriched salt

Treatment:

Other: Potassium and magnesium-enriched salt