Combined Dietary Education of Low Sodium and High Potassium Consumption

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by DongGuk University
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Moo-Yong Rhee, DongGuk University
ClinicalTrials.gov Identifier:
NCT01914224
First received: July 31, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Prehypertension
Hypertension
Behavioral: dietary education of low sodium and high potassium consumption
Behavioral: dietary education of low sodium consumption only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption

Resource links provided by NLM:


Further study details as provided by DongGuk University:

Primary Outcome Measures:
  • changes of 24-hour ambulatory systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education

  • changes of renin and aldosterone [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Difference in changes of renin and aldosterone by each dietary education


Other Outcome Measures:
  • Changes of renin and aldosterone [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes of renin and aldosterone by low sodium consumption

  • Changes of pulse wave velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes of pulse wave velocity by low sodium consumption

  • Changes of left ventricular mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes of left ventricular mass index by low sodium consumption


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
dietary education of low sodium and high potassium consumption
Behavioral: dietary education of low sodium and high potassium consumption
Active Comparator: Group 2
dietary education of low sodium consumption only
Behavioral: dietary education of low sodium consumption only

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914224

Locations
Korea, Republic of
Dongguk University Ilsan Hospital Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-773
Contact: Moo-Yong Rhee, MD, PhD    82 31 961 7125    mooyong.rhee@gmail.com   
Contact: Ji-Hyun Kim, MD, PhD    82 31 961 7270    mdangela79@gmail.com   
Sub-Investigator: Ji-Hyun Kim, MD, PhD         
Principal Investigator: Moo-Yong Rhee, MD, PhD         
Sponsors and Collaborators
DongGuk University
Ministry of Food and Drug Safety, Korea
Investigators
Principal Investigator: Moo-Yong Rhee, MD, PhD DongGuk University
  More Information

No publications provided

Responsible Party: Moo-Yong Rhee, Professor, MD, PhD, DongGuk University
ClinicalTrials.gov Identifier: NCT01914224     History of Changes
Other Study ID Numbers: 13162MFDS106
Study First Received: July 31, 2013
Last Updated: May 20, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by DongGuk University:
Prehypertension
Hypertension
Sodium
Potassium
renin
aldosterone

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014