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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • Xijing Hospital

    Xi’an, Shanxi, 710032

Other trials in China

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 groups in NCT06315543
Study groupRoleWhat they receive
Adequate drinking water intervention groupExperimentalincrease 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 groupNo interventionmaintain original water intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted18 Mar 2024
  2. Study start23 May 2024
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

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)
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

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.

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