Impact of Increased Water Intake in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Hydration

• Registration Number: NCT01766687
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. The investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. The investigators hypothesize that increased water intake will slow renal decline.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Study Start: 2013-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 822

Inclusion Criteria

• Age 18-80 years
• Able to provide informed consent and willing to complete follow-up visits.
• Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2
• Trace protein or greater (Albustix) or urine albumin/creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol (if male) from a random spot urine sample

Exclusion Criteria

• Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.
• Enrolled in another trial that could influence the intervention, outcomes or data collection of this trial (or previously enrolled in this trial)
• Received one or more dialysis treatments in the past month
• Kidney transplant within past six months (or on waiting list)
• Pregnant or breastfeeding
• History of kidney stones in past 5 years
• Less than two years life expectancy
• Serum sodium <130 mEq/L without suitable explanation
• Serum calcium >2.6 mmol/L without suitable explanation
• Currently taking hydrochlorothiazide >25 mg/d, indapamide >1.25 mg/d, furosemide >40 mg, or metolazone >2.5 mg/d
• Currently taking lithium
• Patient is under fluid restriction (<1.5 L a day) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction <40%, NYHA class 3 or 4, or end stage cirrhosis) or ii) hospitalization secondary to heart failure, ascites and/or anasarca
• Patient has GI disease (history of inflammatory bowel disease, Crohns, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydration	Hydration	Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual consumed beverages, for 12 months.

Primary Outcome Measures

Name	Time	Method
Renal decline	Baseline and 12 months	Change in estimated glomerular filtration rate between baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Rapid renal decline	Baseline and 12 months	Proportion with eGFR (estimated glomerular filtration rate) decline \>5% between baseline and 12 months
Copeptin	Baseline and 12 months	Change in copeptin between baseline and 12 months
24-hour urine albumin	Baseline and 12 months	Change in 24-hour urine albumin between baseline and 12 months
Measured creatinine clearance	Baseline and 12 months	Change in measured creatinine clearance between baseline and 12 months
Health-related quality of life	Baseline and 12 months	Change in health-related quality of life between baseline and 12 months

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada