HypertensionNCT03226327
A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension
A study testing formula salt with very low sodium (Brand name: Manlikang) in people with Hypertension and Hypertension With Abnormal Renal Function, run by Peking University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hypertension, Hypertension With Abnormal Renal Function
- What is being tested?
- formula salt with very low sodium (Brand name: Manlikang)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Liver disfunction
- Anyone with abnormal serum potassium in family
- Anyone using potassium-retaining diuretics in family
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- formula salt with very low sodium (Brand name: Manlikang)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| hypertension patients | Experimental | Not described Receives: Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of systolic pressure
the change of systolic pressure before and after taking Manlikang
Measured: baseline and 6 weeks
Secondary outcomes (4)
the change in 24-hour urine sodium
the change of 24-hour urine sodium before and after taking Manlikang
Measured: baseline and 6 weeks
incidence of reducing antihypertensive drug dose
the incidence of reducing antihypertensive drug dose after taking Manlikang in each group.
Measured: up to 6 weeks
incidence of reaching the normal blood pressure
blood pressure reaches the standard of systolic pressure<140mmHg and diastolic pressure<90mmHg after taking Manlikang.
Measured: up to 6 weeks
adverse event
the adverse events after taking Manlikang
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start28 Mar 2018
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangfeng Wu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226327
- Sponsor's protocol ID
- PUCRI20170716
- Status last verified
- Mar 2019
- First submitted
- 19 Jul 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33441669Mu 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.
PubMed 32080135
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03226327
- Acronym / sponsor ID
- PUCRI20170716
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertension patients | Experimental | Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | hypertension patients |
Primary outcome
the change of systolic pressure
Time frame: baseline and 6 weeks
the change of systolic pressure before and after taking Manlikang
4 secondary outcomes
the change in 24-hour urine sodium
Time frame: baseline and 6 weeks
incidence of reducing antihypertensive drug dose
Time frame: up to 6 weeks
incidence of reaching the normal blood pressure
Time frame: up to 6 weeks
adverse event
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 33441669Liu 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.
- Derived from this study: PubMed 32080135Mu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formula salt with very low sodium (Brand name: Manlikang) in people with Hypertension and Hypertension With Abnormal Renal Function, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of systolic pressure (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.