@article{dc0c1f99eab1411aaa6fdba423b95b14,
title = "Interim effects of salt substitution on urinary electrolytes and blood pressure in the China Salt Substitute and Stroke Study (SSaSS)",
abstract = "The Salt Substitute and Stroke Study is an ongoing 5-year large-scale cluster randomized trial investigating the effects of potassium-enriched salt substitute compared to usual salt on the risk of stroke. The study involves 600 villages and 20,996 individuals in rural China. Intermediate risk markers were measured in a random subsample of villages every 12 months over 3 years to track progress against key assumptions underlying study design. Measures of 24-hour urinary sodium, 24-hour urinary potassium, blood pressure and participants{\textquoteright} use of salt substitute were recorded, with differences between intervention and control groups estimated using generalized linear mixed models. The primary outcome of annual event rate in the two groups combined was determined by dividing confirmed fatal and non-fatal strokes by total follow-up time in the first 2 years. The mean differences (95% CI) were -0.32 g (-0.68 to 0.05) for 24-hour urinary sodium, +0.77 g (+0.60 to +0.93) for 24-hour urinary potassium, -2.65 mmHg (-4.32 to -0.97) for systolic blood pressure and +0.30 mmHg (-0.72 to +1.32) for diastolic blood pressure. Use of salt substitute was reported by 97.5% in the intervention group versus 4.2% in the control group (P<.0001). The overall estimated annual event rate for fatal and non-fatal stroke was 3.2%. The systolic blood pressure difference and the annual stroke rate were both in line with the statistical assumptions underlying study design. The trial should be well placed to address the primary hypothesis at completion of follow-up.",
author = "Liping Huang and Maoyi Tian and Jie Yu and Qiang Li and Yishu Liu and Xuejun Yin and Wu, {Jason HY} and Matti Marklund and Yangfeng Wu and Nicole Li and Paul Elliott and Yan, {Lijing L.} and Labarthe, {Darwin R.} and Zhixin Hao and Jingpu Shi and Xiangxian Feng and Jianxin Zhang and Yuhong Zhang and Ruijuan Zhang and Bo Zhou and Zhifang Li and Jixin Sun and Yi Zhao and Yan Yu and Bruce Neal",
note = "Funding Information: SSaSS is an open label, large-scale, cluster-randomized controlled trial registered with clinicaltrials.gov (identifier: NCT02092090). The study is funded by Australian National Health and Medical Research Council with free salt substitute provided by Jiangsu Sinokone Technology Co. Ltd after the first two years of the study. Details of the study design and baseline characteristics of the participants have been previously published. 9 The study has been approved by the University of Sydney Ethics Committee and Peking University Institutional Review Board. All participants have provided written informed consent. This interim analysis reports effects on intermediate markers of risk based upon data from the first three years of follow-up and estimated overall event rates based upon data from the first two years of follow-up. Funding Information: The SSaSS trial is funded by Australian National Health and Medical Research Council (Grant ID: 1049417 & APP1164206). Dr Neal is supported by an NHMRC Principal Research Fellowship (APP1106947). Dr J HY Wu is supported by a UNSW Scientia Fellowship. Ms Huang and Drs Marklund, Neal and J HY Wu, are researchers within a National Health and Medical Research Council Centre for Research Excellence in reducing salt intake using food policy interventions (APP1117300). Funding Information: The SSaSS implementation team and local collaborators. Endpoint Adjudication Committee: Dr Weiping Sun, Dr Junyan Liu, Dr Fang Liu, Dr Yun Jiang, Dr Rong Hu, Dr Yong Peng, and Dr Jie Yu. Data Monitoring Committee: Professor Zhengming Chen, Professor Jonathan Emberson, Professor Peter Sandercock, Professor Paul Whelton, and Ms Sandrine Stepien. The SSaSS trial is funded by Australian National Health and Medical Research Council (Grant ID: 1049417 & APP1164206). Dr Neal is supported by an NHMRC Principal Research Fellowship (APP1106947). Dr J HY Wu is supported by a UNSW Scientia Fellowship. Ms Huang and Drs Marklund, Neal and J HY Wu, are researchers within a National Health and Medical Research Council Centre for Research Excellence in reducing salt intake using food policy interventions (APP1117300). After 24 months, salt substitute has been provided by Jiangsu Sinokone Technology Co. Ltd for free. The company does not participate in any aspect of the study design or implementation. Liping Huang: Software, Formal analysis, Investigation, Data Curation, Writing - Original Draft, Visualization. Maoyi Tian: Investigation, Supervision, Project administration, Funding acquisition. Jie Yu: Data Curation, Project administration. Qiang Li: Methodology, Software. Yishu Liu: Investigation, Data Curation, Project administration. Xuejun Yin: Investigation, Data Curation, Project administration. Jason HY Wu: Writing - Review & Editing. Matti Marklund: Writing - Review & Editing. Yangfeng Wu: Conceptualization, Methodology, Writing - Review & Editing, Funding acquisition. Nicole Li: Conceptualization, Funding acquisition. Paul Elliott: Methodology, Supervision, Writing - Review & Editing. Lijing L. Yan: Conceptualization, Methodology, Writing - Review & Editing. Darwin R. Labarthe: Supervision. Zhixin Hao: Supervision, Project administration. Jingpu Shi: Investigation, Supervision, Resources. Xiangxian Feng: Investigation, Supervision, Resources. Jianxin Zhang: Investigation, Supervision, Resources. Yuhong Zhang: Investigation, Supervision, Resources. Ruijuan Zhang: Investigation, Supervision, Resources. Bo Zhou: Investigation, Data Curation, Project administration, Supervision. Zhifang Li: Investigation, Data Curation, Project administration, Supervision. Jixin Sun: Investigation, Data Curation, Project administration, Supervision. Yi Zhao: Investigation, Data Curation, Project administration, Supervision. Yan Yu: Investigation, Data Curation, Project administration, Supervision. Bruce Neal: Conceptualization, Methodology, Writing - Review & Editing, Supervision, Funding acquisition. Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",
year = "2020",
month = mar,
doi = "10.1016/j.ahj.2019.12.020",
language = "English (US)",
volume = "221",
pages = "136--145",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
}