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

2 november 2026 bijgewerkt door: Xianghui Zhang, Shihezi University

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

800

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Xinjiang
      • Shihezi, Xinjiang, China, 832000
        • Shihezi City People's Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Low-Sodium Salt Group
Voedingssupplement: 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.
Actieve vergelijker: Regular Salt Group
Voedingssupplement: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants With Failure of Hypertension Prevention or Control
Tijdsspanne: 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.
From randomization to Month 12

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
Tijdsspanne: Month 12
Month 12
Change in Systolic Blood Pressure Among Participants With Hypertension
Tijdsspanne: Baseline to Month 12
Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants With Hypertension
Tijdsspanne: Baseline to Month 12
Baseline to Month 12
Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up
Tijdsspanne: Months 3, 6, and 12
Months 3, 6, and 12
Incidence of Hypertension Among Participants Without Hypertension at Baseline
Tijdsspanne: From randomization to Month 12
From randomization to Month 12
Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline
Tijdsspanne: Baseline to Month 12
Baseline to Month 12
Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
Tijdsspanne: Baseline to Month 12
Baseline to Month 12
Proportion of Households With Successful Hypertension Prevention and Control
Tijdsspanne: From randomization to Month 12
From randomization to Month 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shihezi University

Medewerkers

The General Hospital of the Eighth Division (The Third Affiliated Hospital of Shihezi University Medical College)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

20 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HOME-SALT-2026-01
  • KYLL-2026-61 (Andere identificatie: Shihezi City People's Hospital Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Deidentified individual participant data underlying the results reported in publications from this trial may be shared with qualified researchers upon reasonable request and approval by the study investigators. Data sharing will be subject to applicable ethical, privacy, and institutional requirements.

IPD-tijdsbestek voor delen

Beginning 12 months after publication of the primary study results and available for 5 years

IPD-toegangscriteria voor delen

Deidentified individual participant data and supporting information may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and, where applicable, relevant institutional or ethics committees. Data will be shared only for scientifically appropriate purposes and subject to an appropriate data use agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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