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Trial record 4 of 100 for:    salt intake and hypertension

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

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ClinicalTrials.gov Identifier: NCT03226327
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yangfeng Wu, 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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertension With Abnormal Renal Function Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: hypertension patients 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.




Primary Outcome Measures :
  1. the change of systolic pressure [ Time Frame: baseline and 6 weeks ]
    the change of systolic pressure before and after taking Manlikang


Secondary Outcome Measures :
  1. the change in 24-hour urine sodium [ Time Frame: baseline and 6 weeks ]
    the change of 24-hour urine sodium before and after taking Manlikang

  2. incidence of reducing antihypertensive drug dose [ Time Frame: up to 6 weeks ]
    the incidence of reducing antihypertensive drug dose after taking Manlikang in each group.

  3. incidence of reaching the normal blood pressure [ Time Frame: up to 6 weeks ]
    blood pressure reaches the standard of systolic pressure<140mmHg and diastolic pressure<90mmHg after taking Manlikang.

  4. adverse event [ Time Frame: up to 6 weeks ]
    the adverse events after taking Manlikang



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226327


Locations
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China
Maoer Shi community
Chongqing, China, 400000
Sponsors and Collaborators
Peking University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yangfeng Wu, director, Peking University
ClinicalTrials.gov Identifier: NCT03226327    
Other Study ID Numbers: PUCRI20170716
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases