Intervention for Monitoring of Salt Intake in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397054
• Other study ID #: COA. MURA2021/1004
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: Mahidol University
• Contact: PITCHAPORN SONUCH
• Phone: 022011000
• Email: pitch_bell[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Salt; Excess

Intervention

Behavioral:
• Education
- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients
• Reformulation
- Reformulation: Dietary recommendation in low sodium intake
• Environmental change
- Environmental change: Encourage about low sodium intake in community

Device:
• Salt meter
- Used salt meter: at least 3 times/wk

Behavioral:
• standard treatment
standard treatment

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Mahidol University	Thai health promotion foundation., World Health Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour urine sodium excretion	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	12 weeks
Secondary	blood pressure	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	4, 8 12 weeks