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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04286802
Other study ID # 04-60-21
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date February 28, 2020

Study information

Verified date February 2020
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date February 28, 2020
Est. primary completion date February 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Salt-meter
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.
Behavioral:
Education
Program dietary education by certified dietician who did not know the patients arm allocation.

Locations

Country Name City State
Thailand Faculty of Medicine, Ramathibodi Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of patients with hypertensive emergency Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents. 8 weeks
Other Questionnaire about motivation to maintain low salt diet Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks after 8 weeks
Primary 24-hour urinary sodium excretion Change in 24-hour urinary sodium excretion from baseline 8 weeks
Secondary Change in systolic and diastolic blood pressure Changes in systolic and diastolic blood pressure from baseline 8 weeks
Secondary 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. 8 weeks
Secondary Change in cardio-ankle vascular index (CAVI) Change in cardio-ankle vascular index (CAVI) from baseline 8 weeks
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