TY - JOUR
T1 - Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities
T2 - a cluster-randomized trial
AU - Yuan, Yifang
AU - Jin, Aoming
AU - Neal, Bruce
AU - Feng, Xiangxian
AU - Qiao, Qianku
AU - Wang, Hongxia
AU - Zhang, Ruijuan
AU - Li, Jiayu
AU - Duan, Peifen
AU - Cao, La’e
AU - Zhang, Hui
AU - Hu, Senke
AU - Li, Huijuan
AU - Gao, Pei
AU - Xie, Gaoqiang
AU - Yuan, Jianhui
AU - Cheng, Lili
AU - Wang, Sujuan
AU - Zhang, Haijun
AU - Niu, Wenyi
AU - Fang, Hai
AU - Zhao, Minghui
AU - Gao, Runlin
AU - Chen, Junshi
AU - Elliott, Paul
AU - Labarthe, Darwin
AU - Wu, Yangfeng
N1 - Funding Information:
B.N. is supported by a National Health and Medical Research Council Investigator Grant (APP1197709). P.E. is director of the UK Medical Research Council (MRC) Centre for Environment and Health (MR/L01341X/1; MR/S019669/1) and acknowledges support from the National Institute for Health Research (NIHR) Imperial Biomedical Research Centre, the Imperial College British Heart Foundation Centre for Research Excellence (RE/18/4/34215) and the UK Dementia Research Institute at Imperial College London (MC_PC_17114).
Funding Information:
The authors thank all facility residents for their participation and cooperation. We also like to thank all investigators, study team members, facility managers and staff, and administrative agencies for their proactive participation in the study. We are also grateful to K. Liu at the Northwestern University School of Medicine for his advice on study design and statistical analysis plan development. The trial was supported by the National Key Research and Development Program, Ministry of Science and Technology of China, through the research grant ‘Diet, ExerCIse and CarDiovascular hEalth (DECIDE) project’ (2016YFC1300200). China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. The funders of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report.
Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer Nature America, Inc.
PY - 2023/4
Y1 - 2023/4
N2 - There is a paucity of high-quality evidence on the effectiveness and safety of salt reduction strategies, particularly for older people, who have the most to benefit but are at higher risk of adverse effects. Here, we conducted a clinical trial in which 48 residential elderly care facilities in China (1,612 participants including 1,230 men and 382 women, 55 years or older) were cluster-randomized using a 2 × 2 factorial design to provision of salt substitute (62.5% NaCl and 25% KCl) versus usual salt and to a progressively restricted versus usual supply of salt or salt substitute for 2 years. Salt substitute compared with usual salt lowered systolic blood pressure (–7.1 mmHg, 95% confidence interval (CI) –10.5 to –3.8), meeting the primary outcome of the trial, whereas restricted supply compared with usual supply of salt or salt substitute had no effect on systolic blood pressure. Salt substitute also lowered diastolic blood pressure (–1.9 mmHg, 95% CI –3.6 to –0.2) and resulted in fewer cardiovascular events (hazard ratio (HR) 0.60, 95% CI 0.38–0.96), but had no effect on total mortality (HR 0.84, 95% CI 0.63–1.13). From a safety standpoint, salt substitute increased mean serum potassium and led to more frequent biochemical hyperkalemia, but was not associated with adverse clinical outcomes. In contrast, salt restriction had no effect on any study outcome. The results of this trial indicate that use of salt substitute, but not efforts to restrict salt supply, may achieve blood pressure lowering and deliver health benefits to residents of elderly care facilities in China. Clinicaltrials.gov
AB - There is a paucity of high-quality evidence on the effectiveness and safety of salt reduction strategies, particularly for older people, who have the most to benefit but are at higher risk of adverse effects. Here, we conducted a clinical trial in which 48 residential elderly care facilities in China (1,612 participants including 1,230 men and 382 women, 55 years or older) were cluster-randomized using a 2 × 2 factorial design to provision of salt substitute (62.5% NaCl and 25% KCl) versus usual salt and to a progressively restricted versus usual supply of salt or salt substitute for 2 years. Salt substitute compared with usual salt lowered systolic blood pressure (–7.1 mmHg, 95% confidence interval (CI) –10.5 to –3.8), meeting the primary outcome of the trial, whereas restricted supply compared with usual supply of salt or salt substitute had no effect on systolic blood pressure. Salt substitute also lowered diastolic blood pressure (–1.9 mmHg, 95% CI –3.6 to –0.2) and resulted in fewer cardiovascular events (hazard ratio (HR) 0.60, 95% CI 0.38–0.96), but had no effect on total mortality (HR 0.84, 95% CI 0.63–1.13). From a safety standpoint, salt substitute increased mean serum potassium and led to more frequent biochemical hyperkalemia, but was not associated with adverse clinical outcomes. In contrast, salt restriction had no effect on any study outcome. The results of this trial indicate that use of salt substitute, but not efforts to restrict salt supply, may achieve blood pressure lowering and deliver health benefits to residents of elderly care facilities in China. Clinicaltrials.gov
UR - http://www.scopus.com/inward/record.url?scp=85152671968&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85152671968&partnerID=8YFLogxK
U2 - 10.1038/s41591-023-02286-8
DO - 10.1038/s41591-023-02286-8
M3 - Article
C2 - 37055566
AN - SCOPUS:85152671968
SN - 1078-8956
VL - 29
SP - 973
EP - 981
JO - Nature Medicine
JF - Nature Medicine
IS - 4
ER -