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

2. november 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Xinjiang
      • Shihezi, Xinjiang, Kina, 832000
        • Shihezi City People's Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Low-Sodium Salt Group
Kosttilskud: 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.
Aktiv komparator: Regular Salt Group
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Failure of Hypertension Prevention or Control
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shihezi University

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

20. september 2026

Først indsendt, der opfyldte QC-kriterier

20. september 2026

Først opslået (Faktiske)

25. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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