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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Potassium and magnesium-enriched salt; Other: Regular salt; Other: Potassium-enriched salt

• Registration Number: NCT02910427
• Lead Sponsor: Academia Sinica, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-09
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-20
• Last Update Submitted: 2016-09-20
• Study First Posted: 2016-09-22
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K/Mg salt	Potassium and magnesium-enriched salt	potassium and magnesium-enriched salt
Na salt	Regular salt	regular salt
K salt	Potassium-enriched salt	potassium-enriched salt

Primary Outcome Measures

Name	Time	Method
The modified Rankin scale (mRs)	6 months
The Barthel index (BI)	6 months
The National Institute of Health Stroke Scale (NIHSS)	6 months
The "good neurological performance"	6 months	The "good neurological performance" is defined as those who met all of the following criteria: a score of zero in NIHSS, a score of 100 in BI, and a score of equal to or less than 1 in mRS.