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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290716 on ClinicalTrials.gov