Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial (HOME-Salt)
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xianghui Zhang, PhD
- 電話番号：+8618999335467
- メール：zxh818@shzu.edu.cn
研究場所
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Xinjiang
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Shihezi、Xinjiang、中国、832000
- Shihezi City People's Hospital
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コンタクト：
- Qiang Zhang, Master
- 電話番号：+8613899513431
- メール：zhqiang120@126.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Low-Sodium Salt Group
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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. |
|
アクティブコンパレータ：Regular Salt Group
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants With Failure of Hypertension Prevention or Control
時間枠：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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
時間枠：Month 12
|
Month 12
|
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Change in Systolic Blood Pressure Among Participants With Hypertension
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
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Change in Diastolic Blood Pressure Among Participants With Hypertension
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
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Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up
時間枠：Months 3, 6, and 12
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Months 3, 6, and 12
|
|
Incidence of Hypertension Among Participants Without Hypertension at Baseline
時間枠：From randomization to Month 12
|
From randomization to Month 12
|
|
Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
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Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
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Proportion of Households With Successful Hypertension Prevention and Control
時間枠：From randomization to Month 12
|
From randomization to Month 12
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HOME-SALT-2026-01
- KYLL-2026-61 (その他の識別子：Shihezi City People's Hospital Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Beginning 12 months after publication of the primary study results and available for 5 years
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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