HypertensionNCT02016404
The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
A study testing Low-sodium, high-potassium salt and Regular salt in people with Hypertension, run by Wageningen University at 1 site in Vietnam.
Trial summary
The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Low-sodium, high-potassium salt and Regular salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2013to Sep 2013
- 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 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Untreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval
Who cannot join
- Diagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
National Institute of Nutrition (NIN), Department of Community Nutrition
Hanoi, Hai Ba Trung Dist.
About this study
The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.
- Conditions
- Hypertension
- Being tested
- Low-sodium, high-potassium salt, Regular salt
- Keywords
- blood pressure, sodium, salt, low sodium high potassium salt, potassium, Vietnam, randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sodium, high-potassium saltOther
Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation
Regular saltOther
Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt
| Study group | Role | What they receive |
|---|---|---|
| Low-sodium, high-potassium salt | Active comparator | Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, mono sodium glutamate (MSG), sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation Receives: Other: Low-sodium, high-potassium salt |
| Regular salt | Placebo comparator | Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt Receives: Other: Regular salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic blood pressure (SBP)
Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4 6 and 8.
Measured: Change during 8 weeks of intervention
Secondary outcomes (1)
Change in office diastolic blood pressure (DBP)
Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4, 6 and 8.
Measured: Change during 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nutrition, Vietnam
- Responsible party
- Sponsor
- Investigators
- Ha TP Do, Principal investigator, Community Nutrition, National Institute of Nutrition, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016404
- Sponsor's protocol ID
- 0793
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
- ClinicalTrials.gov ID
- NCT02016404
- Acronym / sponsor ID
- 0793
- Conditions
- Hypertension
- Keywords
- blood pressure, sodium, salt, low sodium high potassium salt, potassium, Vietnam, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nutrition, Vietnam
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Dec 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.
The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-sodium, high-potassium salt | Active comparator | Other: Low-sodium, high-potassium saltIodized low-sodium, high-potassium botcanh (a traditional mixture of salt, mono sodium glutamate (MSG), sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation |
| Regular salt | Placebo comparator | Other: Regular saltRegular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Untreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval
Key exclusion criteria (1 listed)
- Diagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease
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 |
|---|---|---|
| Low-sodium, high-potassium saltIodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation | Other | Low-sodium, high-potassium salt |
| Regular saltRegular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt | Other | Regular salt |
Primary outcome
Change in office systolic blood pressure (SBP)
Time frame: Change during 8 weeks of intervention
Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4 6 and 8.
1 secondary outcome
Change in office diastolic blood pressure (DBP)
Time frame: Change during 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- National Institute of Nutrition (NIN), VietnamLink provided by the sponsor.
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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.
Ha TP Do principal investigator
Community Nutrition, National Institute of Nutrition, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-sodium, high-potassium salt and Regular salt in people with Hypertension, run by Wageningen University at 1 site in Vietnam.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Dec 2013. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic blood pressure (SBP) (time frame: Change during 8 weeks of intervention). 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 20 Dec 2013.