Intervention for Monitoring of Salt Intake in Hypertensive Patients
Primary Purpose
Hypertension, Salt; Excess
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Education
Reformulation
Environmental change
Salt meter
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, salt, salt reduction
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
Sites / Locations
- Faculty of Medicine, Ramathibodi Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigator
Control
Arm Description
Education, Reformulation, Environmental change, Used salt meter
standard treatment with standard education
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05397054
First Posted
May 25, 2022
Last Updated
June 5, 2022
Sponsor
Mahidol University
Collaborators
World Health Organization, Thai health promotion foundation.
1. Study Identification
Unique Protocol Identification Number
NCT05397054
Brief Title
Intervention for Monitoring of Salt Intake in Hypertensive Patients
Official Title
Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
World Health Organization, Thai health promotion foundation.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Salt; Excess
Keywords
hypertension, salt, salt reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigator
Arm Type
Experimental
Arm Description
Education, Reformulation, Environmental change, Used salt meter
Arm Title
Control
Arm Type
Active Comparator
Arm Description
standard treatment with standard education
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients
Intervention Type
Behavioral
Intervention Name(s)
Reformulation
Intervention Description
- Reformulation: Dietary recommendation in low sodium intake
Intervention Type
Behavioral
Intervention Name(s)
Environmental change
Intervention Description
- Environmental change: Encourage about low sodium intake in community
Intervention Type
Device
Intervention Name(s)
Salt meter
Intervention Description
- Used salt meter: at least 3 times/wk
Intervention Type
Behavioral
Intervention Name(s)
standard treatment
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
24-hour urine sodium excretion
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
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
Time Frame
4, 8 12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PITCHAPORN SONUCH
Phone
022011000
Email
pitch_bell@hotmail.com
Facility Information:
Facility Name
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PITCHAPORN SONUCH
12. IPD Sharing Statement
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Intervention for Monitoring of Salt Intake in Hypertensive Patients
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