Combined Dietary Education of Low Sodium and High Potassium Consumption

NCT ID: NCT01914224

Last Updated: 2014-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Prehypertension Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

dietary education of low sodium and high potassium consumption

Group Type EXPERIMENTAL

dietary education of low sodium and high potassium consumption

Intervention Type BEHAVIORAL

Group 2

dietary education of low sodium consumption only

Group Type ACTIVE_COMPARATOR

dietary education of low sodium consumption only

Intervention Type BEHAVIORAL

Interventions

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dietary education of low sodium and high potassium consumption

Intervention Type BEHAVIORAL

dietary education of low sodium consumption only

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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Moo-Yong Rhee

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moo-Yong Rhee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Locations

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Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Moo-Yong Rhee, MD, PhD

Role: primary

82 31 961 7125

Ji-Hyun Kim, MD, PhD

Role: backup

82 31 961 7270

Other Identifiers

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13162MFDS106

Identifier Type: -

Identifier Source: org_study_id

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