China Salt Substitute Study (CSSS)
2006
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.
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.
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.
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.
• Hypertension
• Diet
Randomized. Blinded.
Patients Enrolled: 608
Mean Follow-Up: 12 months
Mean Patient Age: Mean age 60 years
% Female: 56
Systolic blood pressure
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
Known indication for or contraindication to the salt substitute
(Enlarge Image)
Figure 1.
China Salt Substitute Study Source: Clinical image provided by the American College of Cardiology Foundation
Year Presented
2006
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.
Drugs/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.
Conditions
• Hypertension
Therapies
• Diet
Study Design
Randomized. Blinded.
Patients Enrolled: 608
Mean Follow-Up: 12 months
Mean Patient Age: Mean age 60 years
% Female: 56
Primary Endpoints
Systolic blood pressure
Patient Population
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
(Enlarge Image)
Figure 1.
China Salt Substitute Study Source: Clinical image provided by the American College of Cardiology Foundation