A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension

A Pilot Trial on Efficacy and Safety of a Formula Salt With Very Low Sodium (Manlikang) in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension in Community

This study is a single arm trial with before-after comparison design. Three groups of patients with hypertension will be recruited: not taking antihypertension drugs and having normal renal function, taking antihypertension drugs and having normal renal function, and having abnormal renal function without regards of antihypertension drugs use. Each group includes 30 patients. Based on renal function test, the investigators provide the Manlikang containing potassium chloride to patients with normal renal function, and provide the Manlikang not containing potassium chloride to patients with abnormal renal function. All hypertension patients will use the formula salt with very low sodium (Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the decrease of patients' systolic blood pressure at the end of the trial.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypertension With Abnormal Renal Function
• Intervention / Treatment: Dietary supplement: formula salt with very low sodium (Brand name: Manlikang)

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400000
    • Maoer Shi community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 50 to 75 years old
• No planning to move out of the community in the next three months
• Not cooking at home less than 3 times or one day during the study
• Willing to participate in the study and sign informed consent

Exclusion Criteria:

• Acute myocardial infarction, history of stroke in the past 3 months, history of malignancy or expected lifetime less than 1 year.
• Hypercortisolism or aldosteronism
• Acute disease, such as upper respiratory infection, fever and diarrhea.
• Incapable of communicating, such as deaf and dumb, dementia, mental disorder.
• Families taking salt substitute currently
• Not willing to use Manlikang in family
• Liver disfunction
• Anyone with abnormal serum potassium in family
• Anyone using potassium-retaining diuretics in family

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypertension patients	Dietary supplement: formula salt with very low sodium (Brand name: Manlikang); hypertension patients will use the formula salt with very low (<20%) sodium （Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the 24-hour urine sodium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of systolic pressure	the change of systolic pressure before and after taking Manlikang	baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change in 24-hour urine sodium	the change of 24-hour urine sodium before and after taking Manlikang	baseline and 6 weeks
incidence of reducing antihypertensive drug dose	the incidence of reducing antihypertensive drug dose after taking Manlikang in each group.	up to 6 weeks
incidence of reaching the normal blood pressure	blood pressure reaches the standard of systolic pressure<140mmHg and diastolic pressure<90mmHg after taking Manlikang.	up to 6 weeks
adverse event	the adverse events after taking Manlikang	up to 6 weeks

Collaborators and Investigators

• Sponsor: Peking University

Publications and helpful links

General Publications

• Liu T, Rao H, Wang M, Xu H, Wang W, Li G, Wang H, Mu L. Comparative analysis of visit and home blood pressure in a pilot trial on the effect of 18% sodium substitute salt on blood pressure. Sci Rep. 2021 Jan 13;11(1):907. doi: 10.1038/s41598-020-79282-2.
• Mu L, Li C, Liu T, Xie W, Li G, Wang M, Wang R, Rao H, He Q, Wang W, Wu Y. A pilot study on efficacy and safety of a new salt substitute with very low sodium among hypertension patients on regular treatment. Medicine (Baltimore). 2020 Feb;99(8):e19263. doi: 10.1097/MD.0000000000019263.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PUCRI20170716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No