NCT03290716: DECIDE-Salt

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

Completed NA Last updated 11 June 2021

What this trial tests

NA trial testing SS in Blood Pressure in 1,612 participants. Completed in 11 May 2021.

Timeline

25 September 2017

Primary endpoint
24 October 2020

11 May 2021

Quick facts

Lead sponsor	Peking University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,612
Start date	25 September 2017
Primary completion	24 October 2020
Estimated completion	11 May 2021
Sites	1 location across China

Drugs / interventions tested

• SS
• SSSC

Conditions studied

• Blood Pressure — all drugs for Blood Pressure →

Sponsor

Peking University

Who can join

55 and older, any sex, with Blood Pressure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial.
   Yuan Y, Jin A, Neal B, Feng X, et al · · 2023 · cited 63× · PMID 37055566 · DOI 10.1038/s41591-023-02286-8
2. Replacing salt with low-sodium salt substitutes (LSSS) for cardiovascular health in adults, children and pregnant women.
   Brand A, Visser ME, Schoonees A, Naude CE. · · 2022 · cited 38× · PMID 35944931 · DOI 10.1002/14651858.cd015207
3. Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults.
   Zhang X, Yuan Y, Li C, Feng X, et al · · 2024 · cited 20× · PMID 38355240 · DOI 10.1016/j.jacc.2023.12.013
4. Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial.
   Lai X, Yuan Y, Wang H, Zhang R, et al · · 2024 · cited 12× · PMID 38345818 · DOI 10.1001/jamanetworkopen.2023.55564
5. Normal range of serum potassium, prevalence of dyskalaemia and associated factors in Chinese older adults: a cross-sectional study.
   Jin A, Zhao M, Sun Y, Feng X, et al · · 2020 · cited 11× · PMID 33127634 · DOI 10.1136/bmjopen-2020-039472
6. Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey.
   Yuan Y, Jin A, Zhao MH, Wang H, et al · · 2023 · cited 6× · PMID 38000815 · DOI 10.1136/bmjopen-2023-077249
7. Experience with 2 years' intervention to progressively reduce salt supply to kitchens in elderly care facilities-challenges and further research: post hoc analysis of the DECIDE-Salt randomized clinical trial.
   Yuan Y, Jin A, Duan P, Cao L, et al · · 2023 · cited 1× · PMID 37919742 · DOI 10.1186/s12916-023-03130-z