Impact of Increased Water Intake in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— WIT  

Official title:

A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766687
• Other study ID #: S-London RCT
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: August 24, 2017
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 822
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Hydration

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Danone Research

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Clark WF, Huang S-H, Garg AX, et al. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Heal Dis. 2017;4:205435811772510. doi:10.1177/2054358117725106.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	Change in Body Mass Index between baseline and 12 months	Baseline and 12 months
Other	Blood pressure	Change in mean arterial blood pressure between baseline and 12 months	Baseline and 12 months
Other	HbA1c	Change in HbA1c between between baseline and 12 months	Baseline and 12 months
Other	Long-term renal decline	Change in estimated glomerular filtration rate between baseline and 24 months	Baseline and 24 months
Other	Effect of fluid coaching on adherence	Change in urine volume between 12 months and 24-months follow-up	12 and 24 months
Primary	Renal decline	Change in estimated glomerular filtration rate between baseline and 12 months	Baseline and 12 months
Secondary	24-hour urine albumin	Change in 24-hour urine albumin between baseline and 12 months	Baseline and 12 months
Secondary	Rapid renal decline	Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months	Baseline and 12 months
Secondary	Measured creatinine clearance	Change in measured creatinine clearance between baseline and 12 months	Baseline and 12 months
Secondary	Health-related quality of life	Change in health-related quality of life between baseline and 12 months	Baseline and 12 months
Secondary	Copeptin	Change in copeptin between baseline and 12 months	Baseline and 12 months