A pilot study on efficacy and safety of a new salt substitute with very low sodium among hypertension patients on regular treatment

OBJECTIVES: To understand the possible effect of a novel salt substitute with very low sodium in reducing blood pressure, salt intake and use of anti-hypertensive medications among patients on regular medications, to inform the future randomized trials. DESIGN: Single-arm pilot trial. SETTING: A community health service center in Chongqing, China. PARTICIPANTS: A total of 43 patients with hypertension taking anti-hypertensive medications regularly. INTERVENTION: Patients received the salt substitute with 18% sodium chloride for 8 weeks. MAIN OUTCOME MEASURES: Patients were followed up weekly for the use of antihypertensive medications and measurements of blood pressure. We collected 24-h urine before and after the trial to measure sodium and potassium intake. RESULTS: Among 39 patients who completed the 8 weeks' intervention, 30.8% patients stopped or reduced anti-hypertensive medications during the trial. For patients that stopped or reduced medication, the mean SBP and DBP before intervention were 122.1 +/- 9.6 and 68.9 +/- 9.4 mm Hg and both did not increase after intervention (SBP change: 2.8 mm Hg (-5.1, 10.8), P = .48; DBP change: 1.8 mm Hg (-2.2, 5.7), P = .38). For the rest patients, the mean SBP and DBP before intervention were 141.6 +/- 16.9 and 74.6 +/- 6.6 mm Hg but reduced significantly after the intervention (SBP change: -16.0 mm Hg (-21.3, -10.6), P < .001; DBP change: -5.5 mm Hg (-8.1, -2.9), P < .001). The 24-h urine sodium decreased (P < .001) and potassium increased (P < .001) among all patients. No severe adverse events were reported. CONCLUSIONS: The novel salt substitute showed potential in reducing blood pressure and use of antihypertensive medications. Further randomized double-blind controlled trial is warranted to validate these findings.Clinical Trial Registration-URL:http://www.clinicaltrials.gov. Unique identifier: NCT03226327.