Clinical trial NCT03226327: A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypertension With Abnormal Renal Function
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: the change of systolic pressure
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: the change in 24-hour urine sodium
timeFrame: baseline and 6 weeks
measure: incidence of reducing antihypertensive drug dose
timeFrame: up to 6 weeks
measure: incidence of reaching the normal blood pressure
timeFrame: up to 6 weeks
measure: adverse event
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Maoer Shi community
Study officials:
References:
citation: 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.
citation: 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.