<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290716</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC130020302</org_study_id>
    <nct_id>NCT03290716</nct_id>
  </id_info>
  <brief_title>Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China</brief_title>
  <acronym>DECIDE-Salt</acronym>
  <official_title>Diet, Exercise and Cardiovascular Health - Effect of Salt Substitute and Stepwise Salt Supply Control in Reducing Blood Pressure in the Elderly in Nursing Homes in China: a Factorial Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changzhi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hohhot Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yangcheng Ophthalmology Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction&#xD;
      Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and&#xD;
      cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in&#xD;
      reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 960&#xD;
      old people from 48 nursing homes in northern China. The 48 nursing homes will be randomised&#xD;
      into the following 4 groups.&#xD;
&#xD;
        1. salt substitute (SS) and stepwise salt supply control (SSSC);&#xD;
&#xD;
        2. SS only;&#xD;
&#xD;
        3. SSSC only; and&#xD;
&#xD;
        4. no SS and no SSSC (control).&#xD;
&#xD;
      The intervention will last over 2 years. The randomization will be conducted centrally after&#xD;
      the baseline survey completed. Primary outcome will be the change in systolic blood pressure.&#xD;
      The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium,&#xD;
      potassium and microalbumin, and incidence of hyperkalemia, hypokalemia, hyponatremia,&#xD;
      cardiovascular events, and all causes death, and incremental cost-effectiveness ratio.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction&#xD;
      Strategies for the Elderly in Nursing Homes in China) is a study in the DECIDE project, which&#xD;
      includes five studies. The others are DECIDE - Diet, DECIDE - Exercise, DECIDE - Obesity in&#xD;
      Children, and DECIDE - Smart Living. The DECIDE - Salt in Elderly study is to evaluate the&#xD;
      effects, safety and cost-effectiveness of salt substitution (SS) and kitchen-based stepwise&#xD;
      salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes.&#xD;
      Specifically, the study aims include:&#xD;
&#xD;
        1. to test if a stepwise salt supply control strategy could significantly reduce systolic&#xD;
           blood pressure among elderly living in nursing homes;&#xD;
&#xD;
        2. to test if replacing regular salt with the market available salt substitute could&#xD;
           significantly reduce systolic blood pressure among elderly living in nursing homes; and&#xD;
&#xD;
        3. to test if the joint effect of the two strategies is larger than that from one of each.&#xD;
&#xD;
      The corresponding null hypotheses that will be tested are:&#xD;
&#xD;
        1. the mean change from the baseline in systolic blood pressure of elderly residents in&#xD;
           nursing homes that are supplied with SS is equal to the mean change from the baseline in&#xD;
           systolic blood pressure of elderly residents in nursing homes that are supplied with&#xD;
           regular salt;&#xD;
&#xD;
        2. the mean change from the baseline in systolic blood pressure of elderly residents in&#xD;
           nursing homes that apply SSSC is equal to the mean change from the baseline in systolic&#xD;
           blood pressure of elderly residents in nursing homes that do not apply SSSC;&#xD;
&#xD;
        3. There is no interaction between the two interventions above.&#xD;
&#xD;
      The study will recruit over 960 old people from 48 nursing homes in northern China, where the&#xD;
      mean salt intake is generally higher than 12 g/day. A 2x2 factorial cluster-randomized trial&#xD;
      will be used to test two independent salt reduction strategies: 1) using salt substitute to&#xD;
      replace the regular salt in the kitchen of nursing homes; and 2) training the nursing manager&#xD;
      to control/reduce, step by step, the amount of salt supplied to the kitchen of nursing homes.&#xD;
      The 48 nursing homes will be randomized to the following 4 groups.&#xD;
&#xD;
        1. salt substitute (SS) and stepwise salt supply control (SSSC);&#xD;
&#xD;
        2. SS only;&#xD;
&#xD;
        3. SSSC only; and&#xD;
&#xD;
        4. no SS and no SSSC (control).&#xD;
&#xD;
      A brief health education on salt and health will be applied to all four groups. The salt&#xD;
      substitute (NaCl 62.5% and KCl 25%) will be centrally provided. And the Train-the-trainers&#xD;
      model will be used to train the nursing home managers how to implement the SSSC.&#xD;
&#xD;
      The intervention will last over 2 years. The baseline examination including three blood&#xD;
      pressure measurements and one 24-hr urine collection will be conducted for all participants.&#xD;
      Fasting blood samples will be drawn for measurement of serum potassium and detect&#xD;
      hyperkalemia, hypokalemia, hyponatremia and renal dysfunction.&#xD;
&#xD;
      The randomization will be conducted centrally by the study coordinating center at Peking&#xD;
      University Clinical Research Institute, after the baseline survey completed.&#xD;
&#xD;
      All participants will be followed up for blood pressure measurements at 6, 12, 18 and 24&#xD;
      months, for serum potassium at 12 and 24 months, and for 24-hr urine collection at 24 months.&#xD;
&#xD;
      Study outcomes:&#xD;
&#xD;
      Primary outcome: The change in systolic blood pressure from baseline to follow-up.&#xD;
&#xD;
      Secondary outcomes: The incidence of hyponatremia, hyperkalemia, hypokalemia and renal&#xD;
      dysfunction from the baseline to 24 months. The change in 24-hr urinary sodium, potassium and&#xD;
      microalbumin from the baseline to 24 months. The change in diastolic blood pressure from&#xD;
      baseline to follow-up. The incremental cost-effectiveness ratio (ICER). The incidence of&#xD;
      cardiovascular events and all causes death during follow up.&#xD;
&#xD;
      Power analysis:&#xD;
&#xD;
      On the assumptions of a 20% dropout rate, an intraclass correlation of 0.02, the number of&#xD;
      clusters of 48 and at least 20 elderly people in each nursing home, and an α value of 0.05,&#xD;
      the study to detect a mean 3.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg)&#xD;
      between the intervention groups would have a power of 0.81. To detect a 4.0 mmHg reduction in&#xD;
      systolic blood pressure (SD, 18 mm Hg), the power of the same sample size would be 0.96.&#xD;
&#xD;
      Statistical analysis: Linear models adjusted for clustering based on participants with&#xD;
      available measures were used to assess continuous outcomes. Frailty survival models that&#xD;
      account for clustering based upon all randomised participants were used for analysis of the&#xD;
      effects on cardiovascular and mortality outcomes. Generalized linear mixed model were used&#xD;
      for analysis of effects on hyperkalemia, hypokalemia, hyponatremia and renal dysfunction..&#xD;
&#xD;
      Ethical considerations:&#xD;
&#xD;
      The study will be submitted to and approved by the Peking University IRB, which has the full&#xD;
      accreditation from AAHRRP. The study salt substitute is the product available on Chinese&#xD;
      market and has been approved manufactured according to the product standards issued by the&#xD;
      ministry of health. The SSSC approach will take every step for 3 months and the biggest step&#xD;
      of salt reduction will be just 10% of the original amount of use. And the study will ensure&#xD;
      an interview will be conducted to collect the feedback before every next step will take&#xD;
      place. The SSSC intervention will stop at any time that elderly people feel unlike the foods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">May 11, 2021</completion_date>
  <primary_completion_date type="Actual">October 24, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in systolic blood pressure from baseline to follow-up</measure>
    <time_frame>baseline、6 month、12 month、18 month and 24-month follow-up</time_frame>
    <description>mmHg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of hyperkalemia</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>A new case of hyperkalemia is defined as having serum potassium &gt;5.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of hypokalemia</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>A new case of hypokalemia is defined as having serum potassium &lt;3.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in 24-hour urinary sodium and potassium</measure>
    <time_frame>baseline and 24-month follow-up</time_frame>
    <description>mmol/d</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in 24-hour urinary microalbumin</measure>
    <time_frame>baseline and 24-month follow-up</time_frame>
    <description>mg/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in diastolic blood pressure from baseline to follow-up</measure>
    <time_frame>baseline、6 month、12 month、18 month and 24-month follow-up</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICER</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>Incremental cost-effectiveness ratio, defined by the difference in the cost for every unit of gain in the pertained effectiveness outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>fatal and nonfatal stroke, fatal and nonfatal myocardial infarction, hospitalization for congestive heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>all causes death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of hyponatremia</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>A new case of hyponatremia is defined as having serum sodium &lt;135 mmol/L at either 12 or 24 months with normal serum sodium at the baseline, regardless of clinical manifestations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of renal dysfunction</measure>
    <time_frame>throughout 24 months of follow-up</time_frame>
    <description>A new case of renal dysfunction is defined as having eGFR &lt;60 at either 12 or 24 months with normal eGFR at the baseline, regardless of clinical manifestations.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1612</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>SS+SSSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salt substitute plus stepwise salt supply control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SS only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salt substitute only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSSC only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stepwise salt supply control only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No salt substitute and no stepwise salt supply control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SS</intervention_name>
    <description>Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.</description>
    <arm_group_label>SS only</arm_group_label>
    <arm_group_label>SS+SSSC</arm_group_label>
    <other_name>Salt substitution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SSSC</intervention_name>
    <description>A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.</description>
    <arm_group_label>SS+SSSC</arm_group_label>
    <arm_group_label>SSSC only</arm_group_label>
    <other_name>Stepwise salt supply control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility of nursing homes:&#xD;
&#xD;
          -  To be eligible, the nursing home must has not participated in any salt reduction or&#xD;
             other intervention trials, has at least 20 residents and has agreed to participate in&#xD;
             the study.&#xD;
&#xD;
        Eligibility of individual elderly:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in the nursing home permanently or expectedly for the coming two years&#xD;
&#xD;
          -  Age less than 55 years.&#xD;
&#xD;
          -  Life expectancy over six months.&#xD;
&#xD;
          -  Provide written informed content.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically confirmed hyperkalemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yangfeng Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mishan Nursing Home</name>
      <address>
        <city>Jincheng</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Yangfeng Wu</investigator_full_name>
    <investigator_title>Prof of Epidemiology and Sciences in Clincial Research</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290716
org study id: 2016YFC130020302
nct id: NCT03290716
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction
      Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and
      cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in
      reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 960
      old people from 48 nursing homes in northern China. The 48 nursing homes will be randomised
      into the following 4 groups.

        1. salt substitute (SS) and stepwise salt supply control (SSSC);

        2. SS only;

        3. SSSC only; and

        4. no SS and no SSSC (control).

      The intervention will last over 2 years. The randomization will be conducted centrally after
      the baseline survey completed. Primary outcome will be the change in systolic blood pressure.
      The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium,
      potassium and microalbumin, and incidence of hyperkalemia, hypokalemia, hyponatremia,
      cardiovascular events, and all causes death, and incremental cost-effectiveness ratio.
The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction
      Strategies for the Elderly in Nursing Homes in China) is a study in the DECIDE project, which
      includes five studies. The others are DECIDE - Diet, DECIDE - Exercise, DECIDE - Obesity in
      Children, and DECIDE - Smart Living. The DECIDE - Salt in Elderly study is to evaluate the
      effects, safety and cost-effectiveness of salt substitution (SS) and kitchen-based stepwise
      salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes.
      Specifically, the study aims include:

        1. to test if a stepwise salt supply control strategy could significantly reduce systolic
           blood pressure among elderly living in nursing homes;

        2. to test if replacing regular salt with the market available salt substitute could
           significantly reduce systolic blood pressure among elderly living in nursing homes; and

        3. to test if the joint effect of the two strategies is larger than that from one of each.

      The corresponding null hypotheses that will be tested are:

        1. the mean change from the baseline in systolic blood pressure of elderly residents in
           nursing homes that are supplied with SS is equal to the mean change from the baseline in
           systolic blood pressure of elderly residents in nursing homes that are supplied with
           regular salt;

        2. the mean change from the baseline in systolic blood pressure of elderly residents in
           nursing homes that apply SSSC is equal to the mean change from the baseline in systolic
           blood pressure of elderly residents in nursing homes that do not apply SSSC;

        3. There is no interaction between the two interventions above.

      The study will recruit over 960 old people from 48 nursing homes in northern China, where the
      mean salt intake is generally higher than 12 g/day. A 2x2 factorial cluster-randomized trial
      will be used to test two independent salt reduction strategies: 1) using salt substitute to
      replace the regular salt in the kitchen of nursing homes; and 2) training the nursing manager
      to control/reduce, step by step, the amount of salt supplied to the kitchen of nursing homes.
      The 48 nursing homes will be randomized to the following 4 groups.

        1. salt substitute (SS) and stepwise salt supply control (SSSC);

        2. SS only;

        3. SSSC only; and

        4. no SS and no SSSC (control).

      A brief health education on salt and health will be applied to all four groups. The salt
      substitute (NaCl 62.5% and KCl 25%) will be centrally provided. And the Train-the-trainers
      model will be used to train the nursing home managers how to implement the SSSC.

      The intervention will last over 2 years. The baseline examination including three blood
      pressure measurements and one 24-hr urine collection will be conducted for all participants.
      Fasting blood samples will be drawn for measurement of serum potassium and detect
      hyperkalemia, hypokalemia, hyponatremia and renal dysfunction.

      The randomization will be conducted centrally by the study coordinating center at Peking
      University Clinical Research Institute, after the baseline survey completed.

      All participants will be followed up for blood pressure measurements at 6, 12, 18 and 24
      months, for serum potassium at 12 and 24 months, and for 24-hr urine collection at 24 months.

      Study outcomes:

      Primary outcome: The change in systolic blood pressure from baseline to follow-up.

      Secondary outcomes: The incidence of hyponatremia, hyperkalemia, hypokalemia and renal
      dysfunction from the baseline to 24 months. The change in 24-hr urinary sodium, potassium and
      microalbumin from the baseline to 24 months. The change in diastolic blood pressure from
      baseline to follow-up. The incremental cost-effectiveness ratio (ICER). The incidence of
      cardiovascular events and all causes death during follow up.

      Power analysis:

      On the assumptions of a 20% dropout rate, an intraclass correlation of 0.02, the number of
      clusters of 48 and at least 20 elderly people in each nursing home, and an α value of 0.05,
      the study to detect a mean 3.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg)
      between the intervention groups would have a power of 0.81. To detect a 4.0 mmHg reduction in
      systolic blood pressure (SD, 18 mm Hg), the power of the same sample size would be 0.96.

      Statistical analysis: Linear models adjusted for clustering based on participants with
      available measures were used to assess continuous outcomes. Frailty survival models that
      account for clustering based upon all randomised participants were used for analysis of the
      effects on cardiovascular and mortality outcomes. Generalized linear mixed model were used
      for analysis of effects on hyperkalemia, hypokalemia, hyponatremia and renal dysfunction..

      Ethical considerations:

      The study will be submitted to and approved by the Peking University IRB, which has the full
      accreditation from AAHRRP. The study salt substitute is the product available on Chinese
      market and has been approved manufactured according to the product standards issued by the
      ministry of health. The SSSC approach will take every step for 3 months and the biggest step
      of salt reduction will be just 10% of the original amount of use. And the study will ensure
      an interview will be conducted to collect the feedback before every next step will take
      place. The SSSC intervention will stop at any time that elderly people feel unlike the foods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: The change in systolic blood pressure from baseline to follow-up
time frame: baseline、6 month、12 month、18 month and 24-month follow-up
description: mmHg
measure: The incidence of hyperkalemia
time frame: throughout 24 months of follow-up
description: A new case of hyperkalemia is defined as having serum potassium >5.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.
measure: The incidence of hypokalemia
time frame: throughout 24 months of follow-up
description: A new case of hypokalemia is defined as having serum potassium <3.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.
measure: The change in 24-hour urinary sodium and potassium
time frame: baseline and 24-month follow-up
description: mmol/d
measure: The change in 24-hour urinary microalbumin
time frame: baseline and 24-month follow-up
description: mg/day
measure: The change in diastolic blood pressure from baseline to follow-up
time frame: baseline、6 month、12 month、18 month and 24-month follow-up
description: mmHg
measure: ICER
time frame: throughout 24 months of follow-up
description: Incremental cost-effectiveness ratio, defined by the difference in the cost for every unit of gain in the pertained effectiveness outcome
measure: Cardiovascular events
time frame: throughout 24 months of follow-up
description: fatal and nonfatal stroke, fatal and nonfatal myocardial infarction, hospitalization for congestive heart failure
measure: Death
time frame: throughout 24 months of follow-up
description: all causes death
measure: The incidence of hyponatremia
time frame: throughout 24 months of follow-up
description: A new case of hyponatremia is defined as having serum sodium <135 mmol/L at either 12 or 24 months with normal serum sodium at the baseline, regardless of clinical manifestations.
measure: The incidence of renal dysfunction
time frame: throughout 24 months of follow-up
description: A new case of renal dysfunction is defined as having eGFR <60 at either 12 or 24 months with normal eGFR at the baseline, regardless of clinical manifestations.
arm group label: SS+SSSC
arm group type: Experimental
description: Salt substitute plus stepwise salt supply control
arm group label: SS only
arm group type: Experimental
description: Salt substitute only
arm group label: SSSC only
arm group type: Experimental
description: Stepwise salt supply control only
arm group label: control
arm group type: No Intervention
description: No salt substitute and no stepwise salt supply control
intervention type: Other
intervention name: SS
description: Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
arm group label: SS only
arm group label: SS+SSSC
other name: Salt substitution
intervention type: Other
intervention name: SSSC
description: A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
arm group label: SS+SSSC
arm group label: SSSC only
other name: Stepwise salt supply control
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Yangfeng Wu, PhD
role: Principal Investigator
affiliation: Peking University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Yangfeng Wu
investigator title: Prof of Epidemiology and Sciences in Clincial Research
sharing ipd: No