Clinical trial NCT02910427: The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
Official title: The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
potassium and magnesium-enriched salt
neurological performance
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 291
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The modified Rankin scale (mRs)
timeFrame: 6 months
measure: The National Institute of Health Stroke Scale (NIHSS)
timeFrame: 6 months
measure: The Barthel index (BI)
timeFrame: 6 months
measure: The "good neurological performance"
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan WH, Lai YH, Yeh WT, Chen JR, Jeng JS, Bai CH, Lin RT, Lee TH, Chang KC, Lin HJ, Hsiao CF, Chern CM, Lien LM, Liu CH, Chen WH, Chang A. Intake of potassium- and magnesium-enriched salt improves functional outcome after stroke: a randomized, multicenter, double-blind controlled trial. Am J Clin Nutr. 2017 Nov;106(5):1267-1273. doi: 10.3945/ajcn.116.148536. Epub 2017 Sep 6.