Skip to main content
OpenTrials
Completed

NCT Number: NCT02910427

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Regular salt

Other

Participants eat a regular salt diet.

Potassium-enriched salt

Other

Participants eat a potassium-enriched salt diet.

Potassium and magnesium-enriched salt

Other

Participants eat a potassium and magnesium-enriched salt diet.

Primary outcomes

  1. The modified Rankin scale (mRs)

    Time frame: 6 months

  2. The National Institute of Health Stroke Scale (NIHSS)

    Time frame: 6 months

  3. The Barthel index (BI)

    Time frame: 6 months

  4. The "good neurological performance"

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Academia Sinica, Taiwan

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2016
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.