Intervention for Monitoring of Salt Intake in Hypertensive Patients

NCT ID: NCT05397054

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Hypertension Salt; Excess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigator

Education, Reformulation, Environmental change, Used salt meter

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

\- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients

Reformulation

Intervention Type BEHAVIORAL

\- Reformulation: Dietary recommendation in low sodium intake

Environmental change

Intervention Type BEHAVIORAL

\- Environmental change: Encourage about low sodium intake in community

Salt meter

Intervention Type DEVICE

\- Used salt meter: at least 3 times/wk

Control

standard treatment with standard education

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type BEHAVIORAL

standard treatment

Interventions

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Education

\- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients

Intervention Type BEHAVIORAL

Reformulation

\- Reformulation: Dietary recommendation in low sodium intake

Intervention Type BEHAVIORAL

Environmental change

\- Environmental change: Encourage about low sodium intake in community

Intervention Type BEHAVIORAL

Salt meter

\- Used salt meter: at least 3 times/wk

Intervention Type DEVICE

standard treatment

standard treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Thai health promotion foundation.

UNKNOWN

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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PITCHAPORN SONUCH

Role: CONTACT

022011000

Facility Contacts

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PITCHAPORN SONUCH

Role: primary

References

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Sonuch P, Aekplakorn W, Pomsanthia N, Boonyagarn N, Makkawan S, Thongchai S, Tosamran W, Kunjang A, Kantachuvesiri S. Community-based intervention for monitoring of salt intake in hypertensive patients: A cluster randomized controlled trial. PLoS One. 2024 Nov 22;19(11):e0311908. doi: 10.1371/journal.pone.0311908. eCollection 2024.

Reference Type DERIVED
PMID: 39576798 (View on PubMed)

Other Identifiers

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COA. MURA2021/1004

Identifier Type: -

Identifier Source: org_study_id

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