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Trial record 1 of 1 for:    DECIDE-Salt
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Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China (DECIDE-Salt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290716
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
Changzhi Medical College
Xian Jiaotong University
Hohhot Center for Disease Control and Prevention
Yangcheng Ophthalmology Hospital
Information provided by (Responsible Party):
Yangfeng Wu, Peking University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Blood Pressure Other: SS Other: SSSC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : October 24, 2020
Actual Study Completion Date : May 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SS+SSSC
Salt substitute plus stepwise salt supply control
Other: SS
Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
Other Name: Salt substitution

Other: SSSC
A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
Other Name: Stepwise salt supply control

Experimental: SS only
Salt substitute only
Other: SS
Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
Other Name: Salt substitution

Experimental: SSSC only
Stepwise salt supply control only
Other: SSSC
A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
Other Name: Stepwise salt supply control

No Intervention: control
No salt substitute and no stepwise salt supply control



Primary Outcome Measures :
  1. 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 ]
    mmHg


Secondary Outcome Measures :
  1. The incidence of hyperkalemia [ Time Frame: throughout 24 months of follow-up ]
    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.

  2. The incidence of hypokalemia [ Time Frame: throughout 24 months of follow-up ]
    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.

  3. The change in 24-hour urinary sodium and potassium [ Time Frame: baseline and 24-month follow-up ]
    mmol/d

  4. The change in 24-hour urinary microalbumin [ Time Frame: baseline and 24-month follow-up ]
    mg/day

  5. 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 ]
    mmHg

  6. ICER [ Time Frame: throughout 24 months of follow-up ]
    Incremental cost-effectiveness ratio, defined by the difference in the cost for every unit of gain in the pertained effectiveness outcome

  7. Cardiovascular events [ Time Frame: throughout 24 months of follow-up ]
    fatal and nonfatal stroke, fatal and nonfatal myocardial infarction, hospitalization for congestive heart failure

  8. Death [ Time Frame: throughout 24 months of follow-up ]
    all causes death

  9. The incidence of hyponatremia [ Time Frame: throughout 24 months of follow-up ]
    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.

  10. The incidence of renal dysfunction [ Time Frame: throughout 24 months of follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility of nursing homes:

  • To be eligible, the nursing home must has not participated in any salt reduction or other intervention trials, has at least 20 residents and has agreed to participate in the study.

Eligibility of individual elderly:

Inclusion Criteria:

  • Living in the nursing home permanently or expectedly for the coming two years
  • Age less than 55 years.
  • Life expectancy over six months.
  • Provide written informed content.

Exclusion Criteria:

  • Clinically confirmed hyperkalemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290716


Locations
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China, Shanxi
Mishan Nursing Home
Jincheng, Shanxi, China
Sponsors and Collaborators
Peking University
Changzhi Medical College
Xian Jiaotong University
Hohhot Center for Disease Control and Prevention
Yangcheng Ophthalmology Hospital
Investigators
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Principal Investigator: Yangfeng Wu, PhD Peking University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yangfeng Wu, Prof of Epidemiology and Sciences in Clincial Research, Peking University
ClinicalTrials.gov Identifier: NCT03290716    
Other Study ID Numbers: 2016YFC130020302
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No