Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315543
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-02-18
Brief Title:
Effect of Increased Daily Water Intake in Patients with Hyperuricemia
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Effect of Increased Daily Water Intake in Patients with Hyperuricemia
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The study design was a multicenter prospective randomized controlled clinical trial with a total of 88 participants Group A n44 Group B n44 1 Inclusion criteria patients with hyperuricemia fasting uric acid between 420-540μmolL 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None