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HypertensionSMAL-SALTNCT04286802

Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

A study testing Salt-meter and Education in people with Hypertension and Salt; Excess, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Salt; Excess
What is being tested?
Salt-meter and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteThailand
Study dates
11 Jul 2017to 28 Feb 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)
  • Diagnosed of hypertension for at least 3 months
  • No adjustment of antihypertensive agents for at least 1 month
  • 24h Urine sodium ≥ 90 mmol/day
  • eGFR ≥ 45 ml/min/1.73 sq.m.

Who cannot join

  • eGFR < 45 ml/min/1.73 sq.m.
  • UACR > 300 mg/g
  • Serum potassium > 6.0 mmol/l
  • Serum sodium < 135 mmol/l
  • Unable to collect 24-hour urine

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine, Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

Other trials in Thailand

About this study

Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.

Read the detailed description

A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed.

Being tested
Salt-meter, Education
Keywords
hypertension, uncontrolled, salt, excess, salt meter
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salt-meterDevice

    Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.

  • EducationBehavioural

    Program dietary education by certified dietician who did not know the patients arm allocation.

Study groups in NCT04286802
Study groupRoleWhat they receive
Salt-meterExperimentalPatients received salt-meter in conjunction with dietary education by trained dietician to help monitoring the salt content in food, as well as usual care by their primary physicians.
Receives: Device: Salt-meter; Behavioral: Education
ControlActive comparatorPatients received dietary education by trained dietician and usual care by their primary physicians.
Receives: Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour urinary sodium excretion

    Change in 24-hour urinary sodium excretion from baseline

    Measured: 8 weeks

Secondary outcomes (3)

  1. Change in systolic and diastolic blood pressure

    Changes in systolic and diastolic blood pressure from baseline

    Measured: 8 weeks

  2. Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds

    Using the different saline concentration in solution. Starting from the lowest to higher concentration, the point when the patient can differentiate from distilled water is called "detection threshold", and the point that patient can identify salty taste is called "recognition" threshold.

    Measured: 8 weeks

  3. Change in cardio-ankle vascular index (CAVI)

    Change in cardio-ankle vascular index (CAVI) from baseline

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start11 Jul 2017
  3. Primary completion21 Feb 2020 (estimated)
  4. Study completion28 Feb 2020 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04286802
Sponsor's protocol ID
04-60-21
Acronym
SMAL-SALT
Status last verified
Feb 2020
First submitted
11 Feb 2020
Last updated
27 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mente A, O'Donnell MJ, Rangarajan S, McQueen MJ, Poirier P, Wielgosz A, Morrison H, Li W, Wang X, Di C, Mony P, Devanath A, Rosengren A, Oguz A, Zatonska K, Yusufali AH, Lopez-Jaramillo P, Avezum A, Ismail N, Lanas F, Puoane T, Diaz R, Kelishadi R, Iqbal R, Yusuf R, Chifamba J, Khatib R, Teo K, Yusuf S; PURE Investigators. Association of urinary sodium and potassium excretion with blood pressure. N Engl J Med. 2014 Aug 14;371(7):601-11. doi: 10.1056/NEJMoa1311989.

    PubMed 25119606

  • Cook NR, Kumanyika SK, Cutler JA, Whelton PK; Trials of Hypertension Prevention Collaborative Research Group. Dose-response of sodium excretion and blood pressure change among overweight, nonhypertensive adults in a 3-year dietary intervention study. J Hum Hypertens. 2005 Jan;19(1):47-54. doi: 10.1038/sj.jhh.1001775.

    PubMed 15343354

  • MacGregor GA, Markandu ND, Sagnella GA, Singer DR, Cappuccio FP. Double-blind study of three sodium intakes and long-term effects of sodium restriction in essential hypertension. Lancet. 1989 Nov 25;2(8674):1244-7. doi: 10.1016/s0140-6736(89)91852-7.

    PubMed 2573761

  • Piovesana Pde M, Sampaio Kde L, Gallani MC. Association between Taste Sensitivity and Self-Reported and Objective Measures of Salt Intake among Hypertensive and Normotensive Individuals. ISRN Nutr. 2012 Oct 24;2013:301213. doi: 10.5402/2013/301213. eCollection 2013.

    PubMed 24967247

  • Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.

    PubMed 19516246

Questions about this trial

What is this clinical trial studying?

A study testing Salt-meter and Education 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 5 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 27 Feb 2020. 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?

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?

24-hour urinary sodium excretion (time frame: 8 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 NCT04286802, which also lists 5 linked publications.

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 27 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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