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Intervention for Monitoring of Salt Intake in Hypertensive Patients

M

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)

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

Trial contacts and locations

1

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Central trial contact

PITCHAPORN SONUCH

Data sourced from clinicaltrials.gov

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