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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226327
• Other study ID #: PUCRI20170716
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: March 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension With Abnormal Renal Function

Intervention

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.

Locations

Country	Name	City	State
China	Maoer Shi community	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of systolic pressure	the change of systolic pressure before and after taking Manlikang	baseline and 6 weeks
Secondary	the change in 24-hour urine sodium	the change of 24-hour urine sodium before and after taking Manlikang	baseline and 6 weeks
Secondary	incidence of reducing antihypertensive drug dose	the incidence of reducing antihypertensive drug dose after taking Manlikang in each group.	up to 6 weeks
Secondary	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
Secondary	adverse event	the adverse events after taking Manlikang	up to 6 weeks