protocolSection identificationModule nctId: NCT06315543, orgStudyIdInfo id: KY20222255-F-1, briefTitle: A Multicentre Clinical Study on the Correlation Between Drinking Water and Hyperuricemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, collaborators name: Air Force 986 Hospital, descriptionModule briefSummary: The name of this study is a multicentre clinical study on the correlation between drinking water and hyperuricemia. The purpose of this study is to clarify the correlation between drinking water and hyperuricemia. 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. 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 renal insufficiency; Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, polycystic ovary syndrome, diabetes mellitus; Patients with secondary hyperuricemia caused by medicine or other diseases; People who have gastrointestinal discomfort or have a history of gastrointestinal surgery, or other people who are not suitable for drinking more water; Patients with mental disorders or communication disorders, and those who did not cooperate during the experiment. A total of 88 subjects were included according to the exclusion criteria. SPSS26.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. The subjects were divided into two groups according to the contents of the envelopes: A constant drinking water observation group (maintaining the original drinking water volume) and B 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). During the 2-week observation period, the effects of constant drinking water and sufficient drinking water on blood uric acid, 24 h uric acid determination, 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 urico-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., conditionsModule conditions: Hyperuricemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Drink water, outcomesModule primaryOutcomes measure: Blood uric acid change, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shanxi, zip: 710032, country: China, contacts name: Li Peng, role: CONTACT, phone: 029-84771794, email: XJYYLLWYH@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False