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

NCT04286802 | Unknown DMC

• 1 other identifier: 04-60-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Salt; Excess

Keywords

hypertension; uncontrolled; salt, excess; salt meter

Outcome Measures

Primary Outcomes (1)

• 24-hour urinary sodium excretion

  Change in 24-hour urinary sodium excretion from baseline

  8 weeks

Secondary Outcomes (3)

• Change in systolic and diastolic blood pressure

  8 weeks

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

  8 weeks

• Change in cardio-ankle vascular index (CAVI)

  8 weeks

Other Outcomes (2)

• Number of patients with hypertensive emergency

  8 weeks

• Questionnaire about motivation to maintain low salt diet

  after 8 weeks

Study Arms (2)

Salt-meter

EXPERIMENTAL

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.

Device: Salt-meter; Behavioral: Education

Control

ACTIVE COMPARATOR

Patients received dietary education by trained dietician and usual care by their primary physicians.

Behavioral: Education

Interventions

Salt-meter DEVICE

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.

Salt-meter

Education BEHAVIORAL

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

Control; Salt-meter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• h Urine sodium ≥ 90 mmol/day
• eGFR ≥ 45 ml/min/1.73 sq.m.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (5)

• 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.

  PMID: 25119606 BACKGROUND

• 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.

  PMID: 15343354 BACKGROUND

• 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.

  PMID: 2573761 BACKGROUND

• 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.

  PMID: 24967247 BACKGROUND

• 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.

  PMID: 19516246 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 27, 2020
• Study Start: July 11, 2017
• Primary Completion: February 21, 2020
• Study Completion: February 28, 2020
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)