Intervention for Monitoring of Salt Intake in Hypertensive Patients

Not Applicable

• Conditions: Hypertension; Salt; Excess
• Interventions: Behavioral: standard treatment; Behavioral: Education; Behavioral: Reformulation; Behavioral: Environmental change; Device: Salt meter

• Registration Number: NCT05397054
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Primary Completion: 2022-05-30
• Study First Posted: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-05
• Last Update Posted: 2022-06-08
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigator	Environmental change	Education, Reformulation, Environmental change, Used salt meter
Investigator	Salt meter	Education, Reformulation, Environmental change, Used salt meter
Control	standard treatment	standard treatment with standard education
Investigator	Education	Education, Reformulation, Environmental change, Used salt meter
Investigator	Reformulation	Education, Reformulation, Environmental change, Used salt meter

Primary Outcome Measures

Name	Time	Method
24-hour urine sodium excretion	12 weeks	Compare the change of 24-hour urine sodium excretion between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment

Secondary Outcome Measures

Name	Time	Method
blood pressure	4, 8 12 weeks	Compare the change systolic and diastolic blood pressure between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment

Trial Locations

Locations (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand