CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,612 enrolled
Drug / intervention
SS +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03290716
NCT03290716N/ACompleted

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

Peking University·interventional·Posted Sep 25, 2017·Updated Jun 11, 2021

In Brief

A clinical study evaluating SS and SSSC for Blood Pressure. Completed, enrolled 1,612 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Pressure
CountriesChina

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 25, 2017
Enrollment StartSep 25, 2017
Primary CompletionOct 24, 2020
Study CompletionMay 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.8 years ago

Interventions

SSother

Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.

SSSCother

A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.