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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910427
• Other study ID #: AS-IRB-BM-08013
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 20, 2016
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Academia Sinica, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board, Academia Sinica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Regular salt
Participants eat a regular salt diet.
• Potassium-enriched salt
Participants eat a potassium-enriched salt diet.
• Potassium and magnesium-enriched salt
Participants eat a potassium and magnesium-enriched salt diet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academia Sinica, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Rankin scale (mRs)		6 months	No
Primary	The National Institute of Health Stroke Scale (NIHSS)		6 months	No
Primary	The Barthel index (BI)		6 months	No
Primary	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	No