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Intervention for Monitoring of Salt Intake in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05397054
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : June 8, 2022
Sponsor:
Collaborators:
World Health Organization
Thai health promotion foundation.
Information provided by (Responsible Party):
Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Salt; Excess Behavioral: Education Behavioral: Reformulation Behavioral: Environmental change Device: Salt meter Behavioral: standard treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigator
Education, Reformulation, Environmental change, Used salt meter
 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
Active Comparator: Control
standard treatment with standard education
 Behavioral: standard treatment
standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397054


Contacts
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Contact: PITCHAPORN SONUCH 022011000 pitch_bell@hotmail.com

Locations
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Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10400
Contact: PITCHAPORN SONUCH         
Sponsors and Collaborators
Mahidol University
World Health Organization
Thai health promotion foundation.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT05397054    
Other Study ID Numbers: COA. MURA2021/1004
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
hypertension
salt
salt reduction
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases