China Salt Substitute Study - CSSS

Description:

The goal of the trial was to evaluate a low sodium, high potassium salt substitute compared with normal salt among individuals in rural northern China at high risk for vascular disease.

Study Design

Patients Enrolled: 608
Mean Follow Up: 12 months
Mean Patient Age: Mean age 60 years
Female: 56

Patient Populations:

High risk of future vascular disease, including one of the following: prior vascular disease, treated diabetes and age ≥55 years, or systolic blood pressure (SBP) ≥160 mmHg; and daily sodium intake ≥260 mmol/24 hours

Exclusions:

Known indication for or contraindication to the salt substitute

Primary Endpoints:

Systolic blood pressure

Drug/Procedures Used:

Following a run-in phase in which all subjects used salt substitute, individuals were randomized in a double-blind manner to replace their usual household salt supply with either study salt substitute (n=306) or normal salt (n=302) for a 12 month period. The salt substitute contained 65% sodium chloride, 25% potassium chloride, 10% magnesium sulphate, and the normal salt contained 100% sodium chloride.

Principal Findings:

At baseline, 71% of patients had a history of vascular disease, and 57% had SBP >160 mm Hg. Antihypertensive medications were used by 61% of patients. Mean baseline blood pressure was 159/93 mmHg.

At 12 months, the mean SBP was reduced by 5.4 mmHg in the salt substitute group compared to the normal salt group (p<0.001). This reduction was evident by 6 months, and the magnitude of the reduction grew progressively during follow-up (p<0.001). Results were similar in the pre-specified subgroups. There was no difference in DBP between the salt substitute and normal salt group at any follow-up timepoint. There was also no difference in urinary sodium concentration, but urinary potassium concentration was significantly increased. Taste as evaluated by saltiness or flavor scale did not differ by group.

Interpretation:

Among individuals in rural northern China at high risk for vascular disease, use of a salt substitute that is lower in sodium concentration than regular salt was associated with a reduction in systolic blood pressure.

The effect of the reduction on SBP with the salt substitute increased over time, without having adverse changes in food taste. The dietary salt consumption among this population in northern China was quite high, and it is unknown if these results would be applicable to populations that do not have as high of an intake of sodium. Additionally, the effect on clinical morbidity and mortality is unknown.

References:

Presented by Dr. Bruce C. Neal at the March 2006 ACC Annual Scientific Session, Atlanta, GA.

China Salt Substitute Study Collaborative Group.Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens. 2007 Oct;25(10):2011-8.

Clinical Topics: Diabetes and Cardiometabolic Disease, Prevention, Diet, Hypertension

Keywords: Magnesium Sulfate, Diet, Sodium-Restricted, Follow-Up Studies, Potassium Chloride, Taste, Hypertension, Diabetes Mellitus, Sodium Chloride, Dietary


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