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Completed

NCT Number: NCT03226327

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Hypertension With Abnormal Renal Function Vascular Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maoer Shi community

Chongqing, 400000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. the change of systolic pressure

    Time frame: baseline and 6 weeks

    the change of systolic pressure before and after taking Manlikang

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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