Back to resultsCombined Dietary Education of Low Sodium and High Potassium Consumption
Primary Purpose
Prehypertension, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dietary education of low sodium and high potassium consumption
dietary education of low sodium consumption only
Sponsored by
About this trial
This is an interventional treatment trial for Prehypertension focused on measuring Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone
Eligibility Criteria
Inclusion Criteria:
- Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg
- 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:
- Urinary tract disease
- Secondary hypertension
- Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months
- Ventricular tachycardia, atrial fibrillation and flutter
- Hypertrophic cardiomyopathy
- Known chronic kidney disease: serum creatinine = or > 2.0 mg/dL
- Hypokalemia (<3.5 mmol/L) or hyperkalemia (>5.5 mmol/L)
- Type 1 diabetes mellitus
- Poorly controlled diabetes mellitus (HbA1C = or > 9%)
- Unable to collect 24 hour urine sample
- Pregnancy
- Alcoholics
- Severe liver disease
- Night workers
- Mental retardation
Sites / Locations
- Dongguk University Ilsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
dietary education of low sodium and high potassium consumption
dietary education of low sodium consumption only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
changes of 24-hour urine sodium and potassium excretion
Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education
changes of renin and aldosterone
Difference in changes of renin and aldosterone by each dietary education
Full Information
NCT ID
NCT01914224
First Posted
July 31, 2013
Last Updated
May 20, 2014
Sponsor
DongGuk University
Collaborators
Ministry of Food and Drug Safety, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01914224
Brief Title
Combined Dietary Education of Low Sodium and High Potassium Consumption
Official Title
Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DongGuk University
Collaborators
Ministry of Food and Drug Safety, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension
Keywords
Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
dietary education of low sodium and high potassium consumption
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
dietary education of low sodium consumption only
Intervention Type
Behavioral
Intervention Name(s)
dietary education of low sodium and high potassium consumption
Intervention Type
Behavioral
Intervention Name(s)
dietary education of low sodium consumption only
Primary Outcome Measure Information:
Title
changes of 24-hour ambulatory systolic and diastolic blood pressure
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
changes of 24-hour urine sodium and potassium excretion
Description
Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education
Time Frame
3 months
Title
changes of renin and aldosterone
Description
Difference in changes of renin and aldosterone by each dietary education
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Changes of renin and aldosterone
Description
Changes of renin and aldosterone by low sodium consumption
Time Frame
3 months
Title
Changes of pulse wave velocity
Description
Changes of pulse wave velocity by low sodium consumption
Time Frame
3 months
Title
Changes of left ventricular mass index
Description
Changes of left ventricular mass index by low sodium consumption
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg
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:
Urinary tract disease
Secondary hypertension
Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months
Ventricular tachycardia, atrial fibrillation and flutter
Hypertrophic cardiomyopathy
Known chronic kidney disease: serum creatinine = or > 2.0 mg/dL
Hypokalemia (<3.5 mmol/L) or hyperkalemia (>5.5 mmol/L)
Type 1 diabetes mellitus
Poorly controlled diabetes mellitus (HbA1C = or > 9%)
Unable to collect 24 hour urine sample
Pregnancy
Alcoholics
Severe liver disease
Night workers
Mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moo-Yong Rhee, MD, PhD
Organizational Affiliation
DongGuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Ilsan Hospital
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-773
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo-Yong Rhee, MD, PhD
Phone
82 31 961 7125
Email
mooyong.rhee@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Kim, MD, PhD
Phone
82 31 961 7270
Email
mdangela79@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Moo-Yong Rhee, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Combined Dietary Education of Low Sodium and High Potassium Consumption
We'll reach out to this number within 24 hrs