Intervention for Monitoring of Salt Intake in Hypertensive Patients

• ClinicalTrials.gov Identifier: NCT05397054
• Recruitment Status: Recruiting
• First Posted: May 31, 2022
• Last Update Posted: June 8, 2022
• Sponsor: Mahidol University
• Collaborators: World Health Organization; Thai health promotion foundation.
• Information provided by (Responsible Party): Mahidol University

Tracking Information

• First Submitted Date: May 25, 2022
• First Posted Date: May 31, 2022
• Last Update Posted Date: June 8, 2022
• Actual Study Start Date: January 10, 2022
• Estimated Primary Completion Date: May 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2022)

24-hour urine sodium excretion [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2022)

blood pressure [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intervention for Monitoring of Salt Intake in Hypertensive Patients
• Official Title: Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension
• Salt; Excess

Intervention

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

Study Arms

• Experimental: Investigator
  Education, Reformulation, Environmental change, Used salt meter
  Interventions:

  • Behavioral: Education
  • Behavioral: Reformulation
  • Behavioral: Environmental change
  • Device: Salt meter
• Active Comparator: Control
  standard treatment with standard education
  Intervention: Behavioral: standard treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 25, 2022): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2022
• Estimated Primary Completion Date: May 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: PITCHAPORN SONUCH; 022011000; pitch_bell@hotmail.com

• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT05397054
• Other Study ID Numbers: COA. MURA2021/1004
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mahidol University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mahidol University
• Original Study Sponsor: Same as current

Collaborators

• World Health Organization
• Thai health promotion foundation.

• Investigators: Not Provided
• PRS Account: Mahidol University
• Verification Date: June 2022