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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., Competing Interests: Declaration of competing interest The funding agencies have no role in writing and publishing this article. The authors are solely responsible for the design, data collection, data analyses, and publication of this study. Yangfeng Wu received a small research grant to evaluate the efficacy and safety of a novel salt substitute manufactured by the Health Source (Chongqing) Cardiovascular Health Technology Co. The other authors declare that there is no conflict of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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' 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., Competing Interests: Disclosures 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., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health., Design: This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine., Trial Status: The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups., Discussion: The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide., (© 2013.)

Objective: To assess the effects of a novel mass media intervention in increasing media reports on salt and health by involving media reporters in a scientifically well designed salt reduction trial. Methods: We recruited and trained 66 media reporters in Changzhi, Shanxi province, China to conduct a randomized controlled trial on blood pressure lowering effect of salt substitute in Dec, 2012 and Jan 2013 among their own relatives or friends (253 from 129 families in the salt substitute arm and 263 from 133 families in the control arm for two months). We shared trial results and other information on salt and health with the reporters within a month after the trial. We monitored all local newspapers for the number of relevant articles in 3 months before, 3 months during and 3 months after the intervention and at the 6th, 12th, 18th, 24th and 48th months after the intervention. Additionally, we conducted two independent surveys on knowledge, belief and behaviours of salt and health among local citizens before and after the intervention. Results: As expected, systolic blood pressure was reduced significantly more in the salt substitute than the control group (-4.7±11.0 mmHg vs -2.6±10.3 mmHg, p<0.001) in the randomized trial. The monthly mean number of relevant articles increased from 0.7 before to 1.7 during (p = 0.263), and further to 6.0 after the intervention (p<0.001), and varied from 2 (p = 0.170) to 4 (p = 0.008) from the 6th to 48th month; the awareness of knowledge on salt and health among local citizens improved significantly after the intervention. Conclusions: Media reporters' participation in a well-designed salt reduction trial significantly increased the number of relevant media reports, and the effect was sustained for a prolonged period. Future mass media public health education programs should consider this innovative strategy for better and sustained impacts. [ABSTRACT FROM AUTHOR]

Background: Average sodium intake and stroke mortality in northern China are both among the highest in the world. An effective, low-cost strategy to reduce sodium intake in this population is urgently needed. Objective: We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China. Design: This study was a cluster-randomized trial done over 18 months in 120 townships (one village from each township) from five provinces. Sixty control villages were compared to 60 intervention villages that were given access to a reduced-sodium, added-potassium salt substitute in conjunction with a community-based health education program focusing on sodium reduction. The primary outcome was the difference in 24-hour urinary sodium excretion between randomized groups. Results: Among 1,903 people with valid 24-hour urine collections, mean urinary sodium excretion in intervention compared with control villages was reduced by 5.5% (-14mmol/day, 95% confidence interval -26 to -1; p = 0.03), potassium excretion was increased by 16% (+7mmol/day, +4 to +10; p<0.001), and sodium to potassium ratio declined by 15% (-0.9, -1.2 to -0.5; p<0.001). Mean blood pressure differences were -1.1 mm Hg systolic (-3.3 to +1.1; p = 0.33) and -0.7 mm Hg diastolic (-2.2 to +0.8, p = 0.35) and the difference in the proportion with hypertension was -1.3% (-5.1 to 2.5, p = 0.56). Conclusion: There were clear differences in population sodium and potassium intake between villages that were most likely a consequence of increased use of salt substitute. The absence of effects on blood pressure reflects the moderate changes in sodium and potassium intake achieved. Trial Registration: Clinicaltrials.gov identifier: . [ABSTRACT FROM AUTHOR]

The relationship between the differential protective effect of salt substitute between hypertensive and normotensive individuals and the use of cardiovascular medications remains unclear. This study involved 4211 individuals with a history of stroke or hypertension who participated in the Salt Substitute and Stroke Study (SSaSS) from 120 villages in Shanxi Province. The aim of this study was to investigate the differences in major adverse cardiovascular events and blood pressure changes between the salt substitute and the regular salt group in the subgroups of participants taking different antihypertensive medications. Mixed models were employed and adjusted for the cluster effect (village) and potential confounding variables. During the average follow‐up period of 4.66 years, a significantly protective effect of salt substitute on reducing the risk of cardiovascular events was observed in the participants who taking antihypertensive medications (rate ratio: 0.81, 95% CI: 0.68 to 0.95. p = 0.011), whereas no significant effect in participants not taking antihypertensive medications (rate ratio: 0.91, 95% CI: 0.62 to 1.32, p = 0.612). Significant effects to lower systolic blood pressure of the salt substitutes were observed in the participants who took different antihypertensive medications. This study emphasized that the use of salt substitutes might enhance the efficacy of anti‐hypertensive medications in lowering blood pressure and reducing the risk of adverse cardiovascular events. [ABSTRACT FROM AUTHOR]

Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. This study sought to assess the effects of a salt substitute (62.5% NaCl, 25% KCl, and 12.5% flavorings) on incidence of hypertension and hypotension among older adults with normal blood pressure. A post hoc analysis was conducted among older adults with normal blood pressure participating in DECIDE-Salt, a large, multicenter, cluster-randomized trial in 48 elderly care facilities for 2 years. We used the frailty survival model to compare risk of incident hypertension and the generalized linear mixed model to compare risk of hypotension episodes. Compared with usual salt group (n = 298), the salt substitute group (n = 313) had a lower hypertension incidence (11.7 vs 24.3 per 100 person-years; adjusted HR: 0.60; 95% CI: 0.39 to 0.92; P = 0.02) but did not increase incidence of hypotension episodes (9.0 vs 9.7 per 100 person-years; P = 0.76). Mean systolic/diastolic blood pressure did not increase from the baseline to the end of intervention in the salt substitute group (mean changes: −0.3 ± 11.9/0.2 ± 7.1 mm Hg) but increased in the usual salt group (7.0 ± 14.3/2.1 ± 7.5 mm Hg), resulting in a net reduction of −8.0 mm Hg (95% CI: −12.4 to –3.7 mm Hg) in systolic and −2.0 mm Hg (95% CI: −4.1 to 0.1 mm Hg) in diastolic blood pressure between intervention groups. In Chinese older adults with normal blood pressure, replacing usual salt with a salt substitute may reduce the incidence of hypertension without increasing hypotension episodes. This suggests a desirable strategy for population-wide prevention and control of hypertension and cardiovascular disease, deserving further consideration in future studies. (Diet Exercise and Cardiovascular Health [DECIDE]—Salt Reduction Strategies for the Elderly in Nursing Homes in China [DECIDE-Salt]; NCT03290716) [Display omitted] [ABSTRACT FROM AUTHOR]