Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients (SMAL-SALT)
Primary Purpose
Hypertension, Salt; Excess
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Salt-meter
Education
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, uncontrolled, salt, excess, salt meter
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Salt-meter
Control
Arm Description
Patients 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.
Patients received dietary education by trained dietician and usual care by their primary physicians.
Outcomes
Primary Outcome Measures
24-hour urinary sodium excretion
Change in 24-hour urinary sodium excretion from baseline
Secondary Outcome Measures
Change in systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure from baseline
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.
Change in cardio-ankle vascular index (CAVI)
Change in cardio-ankle vascular index (CAVI) from baseline
Full Information
NCT ID
NCT04286802
First Posted
February 11, 2020
Last Updated
February 25, 2020
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT04286802
Brief Title
Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
Acronym
SMAL-SALT
Official Title
Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
February 21, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Salt; Excess
Keywords
hypertension, uncontrolled, salt, excess, salt meter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salt-meter
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients received dietary education by trained dietician and usual care by their primary physicians.
Intervention Type
Device
Intervention Name(s)
Salt-meter
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Program dietary education by certified dietician who did not know the patients arm allocation.
Primary Outcome Measure Information:
Title
24-hour urinary sodium excretion
Description
Change in 24-hour urinary sodium excretion from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in systolic and diastolic blood pressure
Description
Changes in systolic and diastolic blood pressure from baseline
Time Frame
8 weeks
Title
Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds
Description
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.
Time Frame
8 weeks
Title
Change in cardio-ankle vascular index (CAVI)
Description
Change in cardio-ankle vascular index (CAVI) from baseline
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Number of patients with hypertensive emergency
Description
Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents.
Time Frame
8 weeks
Title
Questionnaire about motivation to maintain low salt diet
Description
Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks
Time Frame
after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25119606
Citation
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.
Results Reference
background
PubMed Identifier
15343354
Citation
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.
Results Reference
background
PubMed Identifier
2573761
Citation
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.
Results Reference
background
PubMed Identifier
24967247
Citation
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.
Results Reference
background
PubMed Identifier
19516246
Citation
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.
Results Reference
background
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Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
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