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

Sponsors

Lead Sponsor: Peking University

Source Peking University
Brief Summary

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.

Overall Status Completed
Start Date March 28, 2018
Completion Date July 30, 2018
Primary Completion Date July 30, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the change of systolic pressure baseline and 6 weeks
Secondary Outcome
Measure Time Frame
the change in 24-hour urine sodium baseline and 6 weeks
incidence of reducing antihypertensive drug dose up to 6 weeks
incidence of reaching the normal blood pressure up to 6 weeks
adverse event up to 6 weeks
Enrollment 43
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: formula salt with very low sodium (Brand name: Manlikang)

Description: 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.

Arm Group Label: hypertension patients

Eligibility

Criteria:

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

Gender: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Location
Facility: Maoer Shi community
Location Countries

China

Verification Date

March 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking University

Investigator Full Name: Yangfeng Wu

Investigator Title: director

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: hypertension patients

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov