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

NCT ID: NCT03226327

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2018-07-30

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.

Conditions

Hypertension; Hypertension With Abnormal Renal Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hypertension patients

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yangfeng Wu

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maoer Shi community

Chongqing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33441669 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32080135 (View on PubMed)

Other Identifiers

PUCRI20170716

Identifier Type: -

Identifier Source: org_study_id