Impact of Increased Water Intake in Chronic Kidney Disease (WIT)

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: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Hydration

• Study Type: Interventional
• Enrollment (Actual): 822
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Centre

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
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.	Dietary supplement: Hydration

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Change in Body Mass Index between baseline and 12 months	Baseline and 12 months
Blood pressure	Change in mean arterial blood pressure between baseline and 12 months	Baseline and 12 months
HbA1c	Change in HbA1c between between baseline and 12 months	Baseline and 12 months
Long-term renal decline	Change in estimated glomerular filtration rate between baseline and 24 months	Baseline and 24 months
Effect of fluid coaching on adherence	Change in urine volume between 12 months and 24-months follow-up	12 and 24 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Danone Research

Publications and helpful links

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

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: Chronic Kidney Disease; estimated glomerular filtration rate; water intake; fluid intake; renal decline
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: S-London RCT