Aoming Jin1, Kiang Liu2, Darwin R Labarthe2, Xiangxian Feng3, Ruijuan Zhang4, Hongxia Wang5, Qianku Qiao6, Huijuan Li1, Jiayu Li1, Pei Gao7, Hai Fang8, Peifen Duan3, Yuqi Wang4, Hui Zhang5, Lae Cao6, Bruce Neal9, Junshi Chen10, Yangfeng Wu11. 1. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China. 2. Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 3. Changzhi Medical College, Shanxi, China. 4. Xi'an Jiaotong University, Shaanxi, China. 5. Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China. 6. Yangcheng Ophthalmology Hospital, Shanxi, China. 7. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. 8. China Center for Health Development Studies, Peking University, Beijing, China. 9. The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia. 10. National Center for Food Safety Risk Assessment, Beijing, China. 11. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.
Abstract
BACKGROUND: High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed. METHODS: The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. CURRENT STATUS: The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018. CONCLUSION: The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.
RCT Entities:
BACKGROUND: High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed. METHODS: The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. CURRENT STATUS: The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018. CONCLUSION: The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.