A Multicentre Clinical Study on the Correlation Between Drinking Water and Hyperuricemia

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperuricemia
• Intervention / Treatment: Dietary supplement: Drink water

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao Zhang; Phone Number: 18552836301; Email: 1223958434@qq.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Li Peng; Phone Number: 029-84771794; Email: XJYYLLWYH@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Heart, liver and kidney insufficiency
• Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes
• 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
• Those with mental disorders or communication disorders, and those who do not cooperate during the experiment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adequate drinking water intervention group; increase drinking water by 1650mL per day (3 bottles of 550mL bottled water) on the basis of original drinking water	Dietary supplement: Drink water; Increase drinking water by 1650mL per day (3 bottles of 550mL bottled water)
No Intervention: Water intake observation group; maintain original water intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood uric acid change	Changes of uric acid value after drinking water intervention	2 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Air Force 986 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: KY20222255-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No