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NOT YET RECRUITING
NCT07840742
NA

Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial

Sponsor: Shihezi University

View on ClinicalTrials.gov

Summary

Hypertension is a major risk factor for cardiovascular disease. Excess sodium intake and insufficient potassium intake contribute to elevated blood pressure, while replacing regular salt with a potassium-enriched salt substitute may help lower blood pressure. Because cooking salt is commonly shared within households, a household-based salt substitution strategy may provide benefits not only for people with hypertension but also for family members who have not yet developed hypertension. The HOME-Salt Trial is a cluster-randomized, double-blind controlled trial designed to evaluate the effects of household salt substitution on hypertension prevention and control. Eligible households will include at least one adult with diagnosed hypertension and at least one adult without hypertension at baseline. Households will be randomly assigned in a 1:1 ratio to receive either a low-sodium salt substitute or regular salt for 12 months. Approximately 400 households, including at least 800 adults, will be enrolled. Participants, field staff, and outcome assessors will be unaware of treatment assignment. Follow-up assessments will be conducted at 3, 6, and 12 months. The study will evaluate whether household use of low-sodium salt improves blood pressure control among adults with hypertension and reduces the development of hypertension among adults without hypertension at baseline. Blood pressure, medication use, sodium and potassium intake indicators, safety outcomes, and other health-related measures will also be assessed.

Official title: Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-10

Completion Date

2027-12

Last Updated

2026-09-25

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Low-Sodium Salt Substitute

Low-sodium salt containing approximately 75% sodium chloride and 25% potassium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period.

DIETARY_SUPPLEMENT

Regular Salt

Regular salt containing approximately 99.8% sodium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period.

Locations (1)

Shihezi City People's Hospital

Shihezi, Xinjiang, China