NCT01914224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

July 31, 2013

Last Update Submit

May 20, 2014

Conditions

PrehypertensionHypertension

Keywords

PrehypertensionHypertensionSodiumPotassiumreninaldosterone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • changes of 24-hour urine sodium and potassium excretion

    3 months

  • changes of renin and aldosterone

    3 months

Other Outcomes (3)

  • Changes of renin and aldosterone

    3 months

  • Changes of pulse wave velocity

    3 months

  • Changes of left ventricular mass index

    3 months

Study Arms (2)

Group 1

EXPERIMENTAL

dietary education of low sodium and high potassium consumption

Behavioral: dietary education of low sodium and high potassium consumption

Group 2

ACTIVE COMPARATOR

dietary education of low sodium consumption only

Behavioral: dietary education of low sodium consumption only

Interventions

dietary education of low sodium and high potassium consumptionBEHAVIORAL
Group 1
dietary education of low sodium consumption onlyBEHAVIORAL
Group 2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

RECRUITING

MeSH Terms

Conditions

PrehypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Moo-Yong Rhee, MD, PhD

    DongGuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

KR(1)