Impact of Increased Water Intake in Chronic Kidney Disease (WIT)
August 24, 2017 updated by: William Clark, Lawson Health Research Institute
A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
822
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Control
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|
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EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal decline
Time Frame: Baseline and 12 months
|
Change in estimated glomerular filtration rate between baseline and 12 months
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-hour urine albumin
Time Frame: Baseline and 12 months
|
Change in 24-hour urine albumin between baseline and 12 months
|
Baseline and 12 months
|
|
Rapid renal decline
Time Frame: Baseline and 12 months
|
Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months
|
Baseline and 12 months
|
|
Measured creatinine clearance
Time Frame: Baseline and 12 months
|
Change in measured creatinine clearance between baseline and 12 months
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Baseline and 12 months
|
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Health-related quality of life
Time Frame: Baseline and 12 months
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Change in health-related quality of life between baseline and 12 months
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Baseline and 12 months
|
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Copeptin
Time Frame: Baseline and 12 months
|
Change in copeptin between baseline and 12 months
|
Baseline and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Baseline and 12 months
|
Change in Body Mass Index between baseline and 12 months
|
Baseline and 12 months
|
|
Blood pressure
Time Frame: Baseline and 12 months
|
Change in mean arterial blood pressure between baseline and 12 months
|
Baseline and 12 months
|
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HbA1c
Time Frame: Baseline and 12 months
|
Change in HbA1c between between baseline and 12 months
|
Baseline and 12 months
|
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Long-term renal decline
Time Frame: Baseline and 24 months
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Change in estimated glomerular filtration rate between baseline and 24 months
|
Baseline and 24 months
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Effect of fluid coaching on adherence
Time Frame: 12 and 24 months
|
Change in urine volume between 12 months and 24-months follow-up
|
12 and 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Aug 22;4:2054358117725106. doi: 10.1177/2054358117725106. eCollection 2017.
- Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.
- Roussel R, Velho G, Bankir L. Vasopressin and diabetic nephropathy. Curr Opin Nephrol Hypertens. 2017 Jul;26(4):311-318. doi: 10.1097/MNH.0000000000000335.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
January 9, 2013
First Submitted That Met QC Criteria
January 10, 2013
First Posted (ESTIMATE)
January 11, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 25, 2017
Last Update Submitted That Met QC Criteria
August 24, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-London RCT
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