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

Peking University

Status: Completed

Conditions: Hypertension; Hypertension With Abnormal Renal Function

Treatments: Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang)

Study type: Interventional

Funder types: Other

Identifiers

NCT03226327

PUCRI20170716

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

hypertension patients

Experimental group

Treatment:

Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang)