HypertensionNCT05397054
Intervention for Monitoring of Salt Intake in Hypertensive Patients
A study testing Education, Reformulation and Environmental change in people with Hypertension and Salt; Excess, run by Mahidol University at 1 site in Thailand.
Trial summary
Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Salt; Excess
- What is being tested?
- Education, Reformulation and Environmental change
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2022to 30 Jun 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-70 years of age with hypertension
- Systolic blood pressure > 130 mmHg
- Provided informed consent to participate in the study
Who cannot join
- Participants with end stage kidney disease
- History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment
- Pregnant or breastfeeding women
- Adjustment of any antihypertensive agents during study period
- Participants with salt supplement
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, 10400
PITCHAPORN SONUCH
About this study
Official title: Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.
Read the detailed description
A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.
- Conditions
- Hypertension, Salt; Excess
- Being tested
- Education, Reformulation, Environmental change, Salt meter, standard treatment
- Keywords
- hypertension, salt, salt reduction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients
ReformulationBehavioural
- Reformulation: Dietary recommendation in low sodium intake
Environmental changeBehavioural
- Environmental change: Encourage about low sodium intake in community
Salt meterDevice
- Used salt meter: at least 3 times/wk
standard treatmentBehavioural
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Investigator | Experimental | Education, Reformulation, Environmental change, Used salt meter Receives: Behavioral: Education; Behavioral: Reformulation; Behavioral: Environmental change; Device: Salt meter |
| Control | Active comparator | standard treatment with standard education Receives: Behavioral: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine sodium excretion
Compare the change of 24-hour urine sodium excretion between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment
Measured: 12 weeks
Secondary outcomes (1)
blood pressure
Compare the change systolic and diastolic blood pressure between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment
Measured: 4, 8 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Jan 2022
- Primary completion30 May 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Thai health promotion foundation.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397054
- Sponsor's protocol ID
- COA. MURA2021/1004
- Status last verified
- Jun 2022
- First submitted
- 25 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sonuch P, Aekplakorn W, Pomsanthia N, Boonyagarn N, Makkawan S, Thongchai S, Tosamran W, Kunjang A, Kantachuvesiri S. Community-based intervention for monitoring of salt intake in hypertensive patients: A cluster randomized controlled trial. PLoS One. 2024 Nov 22;19(11):e0311908. doi: 10.1371/journal.pone.0311908. eCollection 2024.
PubMed 39576798
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05397054
- Acronym / sponsor ID
- COA. MURA2021/1004
- Conditions
- Hypertension, Salt; Excess
- Keywords
- hypertension, salt, salt reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- World Health Organization, Thai health promotion foundation.
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 31 May 2022 (actual)
- 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.
Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.
Detailed description
A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator | Experimental | Behavioral: Education, Behavioral: Reformulation, Behavioral: Environmental change, Device: Salt meterEducation, Reformulation, Environmental change, Used salt meter |
| Control | Active comparator | Behavioral: standard treatmentstandard treatment with standard education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18-70 years of age with hypertension
- Systolic blood pressure > 130 mmHg
- Provided informed consent to participate in the study
Key exclusion criteria (5 listed)
- Participants with end stage kidney disease
- History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment
- Pregnant or breastfeeding women
- Adjustment of any antihypertensive agents during study period
- Participants with salt supplement
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 |
|---|---|---|
| Education- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients | Behavioural | Investigator |
| Reformulation- Reformulation: Dietary recommendation in low sodium intake | Behavioural | Investigator |
| Environmental change- Environmental change: Encourage about low sodium intake in community | Behavioural | Investigator |
| Salt meter- Used salt meter: at least 3 times/wk | Device | Investigator |
| standard treatmentstandard treatment | Behavioural | Control |
Primary outcome
24-hour urine sodium excretion
Time frame: 12 weeks
Compare the change of 24-hour urine sodium excretion between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment
1 secondary outcome
blood pressure
Time frame: 4, 8 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 39576798Sonuch P, Aekplakorn W, Pomsanthia N, Boonyagarn N, Makkawan S, Thongchai S, Tosamran W, Kunjang A, Kantachuvesiri S. Community-based intervention for monitoring of salt intake in hypertensive patients: A cluster randomized controlled trial. PLoS One. 2024 Nov 22;19(11):e0311908. doi: 10.1371/journal.pone.0311908. eCollection 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Reformulation and Environmental change in people with Hypertension and Salt; Excess, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 5 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 8 Jun 2022. 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 Thailand. 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?
Contact PITCHAPORN SONUCH (022011000, pitch_bell@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine sodium excretion (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397054, which also lists 1 linked publication.
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 8 Jun 2022.