HyperuricemiaNCT06315543
Effect of Increased Daily Water Intake in Patients With Hyperuricemia
A study testing Drink water in people with Hyperuricemia, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Drink water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2024to 27 Nov 2024
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hyperuricemia (fasting uric acid values between 420-540μmol/L twice on different days and no drug treatment)
- Men between the ages of 18-65
- Daily water intake of less than 1500 mL recommended by the minimum dietary guidelines (assessed by dietary review combined with water diary)
- Fully informed consent, sign informed consent
Who cannot join
- Patients with heart, liver and kidney insufficiency.
- Patients with severe or uncontrollable organic diseases that may interfere with the study parameters (such as tumors, cardiovascular, pulmonary and digestive diseases, hypertension, hyperlipidemia, hyperglycemia, thyroid diseases) or psychiatric disorders that affect eating behavior (such as primary polydipsia, bulimia nervosa, Psychiatric disorders, etc.).
- Patients with secondary hyperuricemia caused by other diseases.
- Patients who have taken any drug that causes changes in uric acid within five half-lives of the drug.
- Receiving treatment that can change the assessment of hydration status in the study (taking diuretics, glucocorticoids, or treatments that interfere with metabolism).
- Those who have gastrointestinal discomfort or a history of gastrointestinal surgery after drinking water, and other patients who are not suitable to drink too much water.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants (Group A n=44; Group B n=44). 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: Patients with heart, liver and kidney insufficiency; Patients with severe or uncontrollable organic diseases that may interfere with the study parameters (such as tumors, cardiovascular, pulmonary and digestive diseases, hypertension, hyperlipidemia, hyperglycemia, thyroid diseases) or psychiatric disorders that affect eating behavior (such as primary polydipsia, bulimia nervosa, Psychiatric disorders, etc.); Patients with secondary hyperuricemia caused by other diseases; Patients who have taken any drug that causes changes in uric acid within five half-lives of the drug; Receiving treatment that can change the assessment of hydration status in the study (taking diuretics, glucocorticoids, or treatments that interfere with metabolism); Those who have gastrointestinal discomfort or a history of gastrointestinal surgery after drinking water, and other patients who are not suitable to drink too much water. A total of 88 subjects were included according to the exclusion criteria. The subjects were divided into two groups: Group A adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume); Group B constant drinking water observation group (maintaining the original drinking water volume). During the 2-week observation period, the effects of sufficient drinking water on blood uric acid, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored.
Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take uric-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate.
- Conditions
- Hyperuricemia
- Being tested
- Drink water
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink waterDietary supplement
Increase drinking water by 1650mL per day (3 bottles of 550mL bottled water)
| Study group | Role | What they receive |
|---|---|---|
| Adequate drinking water intervention group | Experimental | increase drinking water by 1650mL per day (3 bottles of 550mL bottled water) on the basis of original drinking water Receives: Dietary Supplement: Drink water |
| Water intake observation group | No intervention | maintain original water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood uric acid change
Changes of uric acid value after drinking water intervention
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start23 May 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315543
- Sponsor's protocol ID
- KY20222255-F-1
- Status last verified
- Jan 2024
- First submitted
- 18 Feb 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Daily Water Intake in Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT06315543
- Acronym / sponsor ID
- KY20222255-F-1
- Conditions
- Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 18 Mar 2024 (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.
The purpose of this study is to explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants (Group A n=44; Group B n=44). 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: Patients with heart, liver and kidney insufficiency; Patients with severe or uncontrollable organic diseases that may interfere with the study parameters (such as tumors, cardiovascular, pulmonary and digestive diseases, hypertension, hyperlipidemia, hyperglycemia, thyroid diseases) or psychiatric disorders that affect eating behavior (such as primary polydipsia, bulimia nervosa, Psychiatric disorders, etc.); Patients with secondary hyperuricemia caused by other diseases; Patients who have taken any drug that causes changes in uric acid within five half-lives of the drug; Receiving treatment that can change the assessment of hydration status in the study (taking diuretics, glucocorticoids, or treatments that interfere with metabolism); Those who have gastrointestinal discomfort or a history of gastrointestinal surgery after drinking water, and other patients who are not suitable to drink too much water. A total of 88 subjects were included according to the exclusion criteria. The subjects were divided into two groups: Group A adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume); Group B constant drinking water observation group (maintaining the original drinking water volume). During the 2-week observation period, the effects of sufficient drinking water on blood uric acid, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored.
Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take uric-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adequate drinking water intervention group | Experimental | Dietary Supplement: Drink waterincrease drinking water by 1650mL per day (3 bottles of 550mL bottled water) on the basis of original drinking water |
| Water intake observation group | No intervention | –maintain original water intake |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hyperuricemia (fasting uric acid values between 420-540μmol/L twice on different days and no drug treatment)
- Men between the ages of 18-65
- Daily water intake of less than 1500 mL recommended by the minimum dietary guidelines (assessed by dietary review combined with water diary)
- Fully informed consent, sign informed consent
Key exclusion criteria (6 listed)
- Patients with heart, liver and kidney insufficiency.
- Patients with severe or uncontrollable organic diseases that may interfere with the study parameters (such as tumors, cardiovascular, pulmonary and digestive diseases, hypertension, hyperlipidemia, hyperglycemia, thyroid diseases) or psychiatric disorders that affect eating behavior (such as primary polydipsia, bulimia nervosa, Psychiatric disorders, etc.).
- Patients with secondary hyperuricemia caused by other diseases.
- Patients who have taken any drug that causes changes in uric acid within five half-lives of the drug.
- Receiving treatment that can change the assessment of hydration status in the study (taking diuretics, glucocorticoids, or treatments that interfere with metabolism).
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 |
|---|---|---|
| Drink waterIncrease drinking water by 1650mL per day (3 bottles of 550mL bottled water) | Dietary supplement | Adequate drinking water intervention group |
Primary outcome
Blood uric acid change
Time frame: 2 weeks
Changes of uric acid value after drinking water intervention
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 27 Dec 2024.
Related trials for Hyperuricemia
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
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 Drink water in people with Hyperuricemia, run by Xijing Hospital 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 6 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 27 Dec 2024. 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?
Blood uric acid change (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.