NCT05397054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

May 25, 2022

Last Update Submit

June 5, 2022

Conditions

HypertensionSalt; Excess

Keywords

hypertensionsaltsalt reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • blood pressure

    4, 8 12 weeks

Study Arms (2)

Investigator

EXPERIMENTAL

Education, Reformulation, Environmental change, Used salt meter

Behavioral: EducationBehavioral: ReformulationBehavioral: Environmental changeDevice: Salt meter

Control

ACTIVE COMPARATOR

standard treatment with standard education

Behavioral: standard treatment

Interventions

EducationBEHAVIORAL

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

Investigator
ReformulationBEHAVIORAL

\- Reformulation: Dietary recommendation in low sodium intake

Investigator
Environmental changeBEHAVIORAL

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

Investigator
Salt meterDEVICE

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

Investigator
standard treatmentBEHAVIORAL

standard treatment

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18-70 years of age with hypertension
  • Systolic blood pressure \> 130 mmHg
  • Provided informed consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39576798DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

PITCHAPORN SONUCH

CONTACT

022011000pitch_bell@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

January 10, 2022

Primary Completion

May 30, 2022

Study Completion

June 30, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

TH(1)