Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07840742

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shihezi City People's Hospital

Shihezi, Xinjiang, 832000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Household-level criteria:

The household includes at least one adult aged 18 years or older with diagnosed hypertension.

The household includes at least one adult aged 18 years or older without hypertension at baseline.

Household members primarily share cooking and meals. All adult household members intended to be included in study evaluations provide written informed consent.

-Participant-level criteria: Aged 18 years or older. Long-term resident of the study area with no plan to move away during the following 12 months.

Consumes most meals at home. Provides written informed consent.

Exclusion criteria

  • Household-level criteria:

The household is currently using low-sodium salt or another potassium-containing salt substitute on a long-term basis.

Any household member who routinely shares meals has a contraindication to potassium-enriched salt or is at increased risk of hyperkalemia, including chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², a history of dialysis, or a history of hyperkalemia.

Any household member who routinely shares meals is pregnant. Any household member who routinely shares meals has hyperthyroidism.

-Participant-level criteria: Currently participating in another interventional study that may affect blood pressure, sodium or potassium intake, or study outcomes.

Serious cardiovascular or cerebrovascular disease, severe liver disease, malignant tumor, severe mental illness, cognitive impairment, or another condition considered unsuitable for study participation.

Unable to complete follow-up visits, standardized blood pressure measurements, or required data collection.

Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.

Treatment and study plan

Low-sodium salt substitute

Dietary Supplement

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.

Regular Salt

Dietary Supplement

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.

Primary outcomes

  1. Proportion of Participants With Failure of Hypertension Prevention or Control

    Time frame: From randomization to Month 12

    A participant-level composite outcome. For participants with hypertension at baseline, failure of hypertension control is defined as a mean systolic blood pressure (SBP) ≥140 mmHg and/or mean diastolic blood pressure (DBP) ≥90 mmHg based on three standardized office blood pressure measurements at Month 12. For participants without hypertension at baseline, failure of hypertension prevention is defined as incident hypertension during follow-up, including a mean SBP ≥140 mmHg and/or mean DBP ≥90 mmHg based on three standardized office measurements, a new diagnosis of hypertension, or initiation of antihypertensive medication.

Secondary outcomes

  1. Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12

    Time frame: Month 12

  2. Change in Systolic Blood Pressure Among Participants With Hypertension

    Time frame: Baseline to Month 12

  3. Change in Diastolic Blood Pressure Among Participants With Hypertension

    Time frame: Baseline to Month 12

  4. Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up

    Time frame: Months 3, 6, and 12

  5. Incidence of Hypertension Among Participants Without Hypertension at Baseline

    Time frame: From randomization to Month 12

  6. Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline

    Time frame: Baseline to Month 12

  7. Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline

    Time frame: Baseline to Month 12

  8. Proportion of Households With Successful Hypertension Prevention and Control

    Time frame: From randomization to Month 12

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Shihezi University

Other

Collaborators

  • Shihezi City People's Hospital

Registry information

Official study title

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

Acronym: HOME-Salt

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.