Combined Dietary Education of Low Sodium and High Potassium Consumption

Hypertension Clinical Trial

Official title:

Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914224
• Other study ID #: 13162MFDS106
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2013
• Last updated: May 20, 2014
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Reduction in sodium consumption is important approach in public health care. In general population, reduction of sodium intake can reduce the future development of hypertension and cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to reduce blood pressure and cardiovascular events. We hypothesized that combined education of low sodium and high potassium consumption is more effective in reducing blood pressure compared to dietary education of low sodium consumption only.

The present survey study was designed to test the effectiveness of combined education of low sodium and high potassium consumption in blood pressure reduction and improvement of other variables.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg

2. Stage 1 hypertension: with a systolic pressure from 140 to 159 mm Hg or a diastolic pressure from 90 to 99 mm Hg

Exclusion Criteria:

1. Urinary tract disease

2. Secondary hypertension

3. Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months

4. Ventricular tachycardia, atrial fibrillation and flutter

5. Hypertrophic cardiomyopathy

6. Known chronic kidney disease: serum creatinine = or > 2.0 mg/dL

7. Hypokalemia (<3.5 mmol/L) or hyperkalemia (>5.5 mmol/L)

8. Type 1 diabetes mellitus

9. Poorly controlled diabetes mellitus (HbA1C = or > 9%)

10. Unable to collect 24 hour urine sample

11. Pregnancy

12. Alcoholics

13. Severe liver disease

14. Night workers

15. Mental retardation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Behavioral:
• dietary education of low sodium and high potassium consumption

• dietary education of low sodium consumption only

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
DongGuk University	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of renin and aldosterone	Changes of renin and aldosterone by low sodium consumption	3 months	No
Other	Changes of pulse wave velocity	Changes of pulse wave velocity by low sodium consumption	3 months	No
Other	Changes of left ventricular mass index	Changes of left ventricular mass index by low sodium consumption	3 months	No
Primary	changes of 24-hour ambulatory systolic and diastolic blood pressure	Effectiveness of combined dietary education of low sodium and high potassium consumption on changes of 24-hour ambulatory systolic and diastolic blood pressure, compared to dietary education of low sodium consumption only.	3 months	No
Secondary	changes of 24-hour urine sodium and potassium excretion	Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education	3 months	No
Secondary	changes of renin and aldosterone	Difference in changes of renin and aldosterone by each dietary education	3 months	No