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

NCT02910427 | Completed DMC

• 1 other identifier: AS-IRB-BM-08013
• Study Type: interventional
• Target: 291
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; potassium and magnesium-enriched salt; neurological performance

Outcome Measures

Primary Outcomes (4)

• The modified Rankin scale (mRs)

  6 months

• The National Institute of Health Stroke Scale (NIHSS)

  6 months

• The Barthel index (BI)

  6 months

• The "good neurological performance"

  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.

  6 months

Study Arms (3)

Na salt

PLACEBO COMPARATOR

regular salt

Other: Regular salt

K salt

ACTIVE COMPARATOR

potassium-enriched salt

Other: Potassium-enriched salt

K/Mg salt

ACTIVE COMPARATOR

potassium and magnesium-enriched salt

Other: Potassium and magnesium-enriched salt

Interventions

Regular salt OTHER

Participants eat a regular salt diet.

Na salt

Potassium-enriched salt OTHER

Participants eat a potassium-enriched salt diet.

K salt

Potassium and magnesium-enriched salt OTHER

Participants eat a potassium and magnesium-enriched salt diet.

K/Mg salt

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead

Related Publications (1)

• 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.

  PMID: 28877896 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Potassium

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Wen-Harn Pan, Ph.D.

  Institute of Biomedical Sciences, Academia Sinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 22, 2016
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 22, 2016

Record last verified: 2016-09