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

NCT ID: NCT02910427

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Na salt

regular salt

Group Type: PLACEBO_COMPARATOR

Regular salt

Intervention Type: OTHER

Participants eat a regular salt diet.

K salt

potassium-enriched salt

Group Type: ACTIVE_COMPARATOR

Potassium-enriched salt

Intervention Type: OTHER

Participants eat a potassium-enriched salt diet.

K/Mg salt

potassium and magnesium-enriched salt

Group Type: ACTIVE_COMPARATOR

Potassium and magnesium-enriched salt

Intervention Type: OTHER

Participants eat a potassium and magnesium-enriched salt diet.

Interventions

Regular salt

Participants eat a regular salt diet.

Intervention Type: OTHER

Potassium-enriched salt

Participants eat a potassium-enriched salt diet.

Intervention Type: OTHER

Potassium and magnesium-enriched salt

Participants eat a potassium and magnesium-enriched salt diet.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academia Sinica, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Wen-Harn Pan

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen-Harn Pan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Biomedical Sciences, Academia Sinica

References

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.

Reference Type: DERIVED

PMID: 28877896 (View on PubMed)

Other Identifiers

AS-IRB-BM-08013

Identifier Type: -

Identifier Source: org_study_id