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Clinical Trial
. 2020 Feb;99(8):e19263.
doi: 10.1097/MD.0000000000019263.

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

Lihong Mu  1 , Chenglong Li  2 , Ting Liu  1 , Wuxiang Xie  2 , Ge Li  1 , Meixian Wang  1 , Ruoxi Wang  1 , Huakun Rao  1 , Qin He  3 , Wen Wang  3 , Yangfeng Wu  2
Affiliations
Clinical Trial

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

Lihong Mu et al. Medicine (Baltimore). 2020 Feb.

Abstract

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.

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Figures

Figure 1
Figure 1
Trend over time of systolic and diastolic blood pressure for per protocol analysis, P values were calculated for the time effect using linear mixed models, after adjusting for sex, age, body mass index, and use of antihypertensive drugs. DBP = diastolic blood pressure, SBP = systolic blood pressure. Area of the shadow was indicative of the 95% confidence interval.
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