Intervention for Monitoring of Salt Intake in Hypertensive Patients

Mahidol University

Status: Enrolling

Conditions: Hypertension; Salt; Excess

Treatments: Device: Salt meter; Behavioral: Education; Behavioral: Environmental change; Behavioral: standard treatment; Behavioral: Reformulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05397054

COA. MURA2021/1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18-70 years of age with hypertension
• Systolic blood pressure > 130 mmHg
• Provided informed consent to participate in the study

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Investigator

Experimental group

Description:

Education, Reformulation, Environmental change, Used salt meter

Treatment:

Device: Salt meter

Behavioral: Environmental change

Behavioral: Reformulation

Behavioral: Education

Control

Active Comparator group

Description:

standard treatment with standard education

Treatment:

Behavioral: standard treatment