Combined Dietary Education of Low Sodium and High Potassium Consumption

Not Applicable

• Conditions: Prehypertension; Hypertension
• Interventions: Behavioral: dietary education of low sodium consumption only; Behavioral: dietary education of low sodium and high potassium consumption

• Registration Number: NCT01914224
• Lead Sponsor: DongGuk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	dietary education of low sodium consumption only	dietary education of low sodium consumption only
Group 1	dietary education of low sodium and high potassium consumption	dietary education of low sodium and high potassium consumption

Primary Outcome Measures

Name	Time	Method
changes of 24-hour ambulatory systolic and diastolic blood pressure	3 months	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.

Secondary Outcome Measures

Name	Time	Method
changes of renin and aldosterone	3 months	Difference in changes of renin and aldosterone by each dietary education
changes of 24-hour urine sodium and potassium excretion	3 months	Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of