PrehypertensionNCT01914224
Combined Dietary Education of Low Sodium and High Potassium Consumption
A study testing dietary education of low sodium and high potassium consumption and dietary education of low sodium consumption only in people with Prehypertension and Hypertension, run by DongGuk University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- dietary education of low sodium and high potassium consumption and dietary education of low sodium consumption only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
Moo-Yong Rhee, MD, PhD, 82 31 961 7125, mooyong.rhee@gmail.com
Ji-Hyun Kim, MD, PhD, 82 31 961 7270, mdangela79@gmail.com
About this study
Official title: Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption
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.
- Conditions
- Prehypertension, Hypertension
- Being tested
- dietary education of low sodium and high potassium consumption, dietary education of low sodium consumption only
- Keywords
- Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary education of low sodium and high potassium consumptionBehavioural
dietary education of low sodium consumption onlyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | dietary education of low sodium and high potassium consumption Receives: Behavioral: dietary education of low sodium and high potassium consumption |
| Group 2 | Active comparator | dietary education of low sodium consumption only Receives: Behavioral: dietary education of low sodium consumption only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
changes of 24-hour urine sodium and potassium excretion
Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education
Measured: 3 months
changes of renin and aldosterone
Difference in changes of renin and aldosterone by each dietary education
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Principal investigator, Moo-Yong Rhee, DongGuk University
- Investigators
- Moo-Yong Rhee, MD, PhD, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914224
- Sponsor's protocol ID
- 13162MFDS106
- Status last verified
- May 2014
- First submitted
- 31 Jul 2013
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption
- ClinicalTrials.gov ID
- NCT01914224
- Acronym / sponsor ID
- 13162MFDS106
- Conditions
- Prehypertension, Hypertension
- Keywords
- Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: dietary education of low sodium and high potassium consumptiondietary education of low sodium and high potassium consumption |
| Group 2 | Active comparator | Behavioral: dietary education of low sodium consumption onlydietary education of low sodium consumption only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary education of low sodium and high potassium consumption | Behavioural | Group 1 |
| dietary education of low sodium consumption only | Behavioural | Group 2 |
Primary outcome
changes of 24-hour ambulatory systolic and diastolic blood pressure
Time frame: 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.
2 secondary outcomes
changes of 24-hour urine sodium and potassium excretion
Time frame: 3 months
changes of renin and aldosterone
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
Related trials for Prehypertension
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Not yet recruiting
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo-Yong Rhee, MD, PhD principal investigator
DongGuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary education of low sodium and high potassium consumption and dietary education of low sodium consumption only in people with Prehypertension and Hypertension, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of 24-hour ambulatory systolic and diastolic blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.