Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China
NCT03290716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1612
Last updated 2021-06-11
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.
Conditions
- Blood Pressure
Interventions
- OTHER
-
SS
Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
- OTHER
-
SSSC
A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
Sponsors & Collaborators
-
Changzhi Medical College
collaborator OTHER -
Xi'an Jiaotong University
collaborator OTHER -
Hohhot Center for Disease Control and Prevention
collaborator UNKNOWN -
Yangcheng Ophthalmology Hospital
collaborator UNKNOWN -
Peking University
lead OTHER
Principal Investigators
-
Yangfeng Wu, PhD · Peking University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-25
- Primary Completion
- 2020-10-24
- Completion
- 2021-05-11
Countries
- China
Study Locations
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