Clinical trial NCT01766687: Impact of Increased Water Intake in Chronic Kidney Disease
Official title: A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
estimated glomerular filtration rate
water intake
fluid intake
renal decline
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2013-01-11
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Renal decline
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: 24-hour urine albumin
timeFrame: Baseline and 12 months
measure: Rapid renal decline
timeFrame: Baseline and 12 months
measure: Measured creatinine clearance
timeFrame: Baseline and 12 months
measure: Health-related quality of life
timeFrame: Baseline and 12 months
measure: Copeptin
timeFrame: Baseline and 12 months
Other outcomes:
measure: Body Mass Index
timeFrame: Baseline and 12 months
measure: Blood pressure
timeFrame: Baseline and 12 months
measure: HbA1c
timeFrame: Baseline and 12 months
measure: Long-term renal decline
timeFrame: Baseline and 24 months
measure: Effect of fluid coaching on adherence
timeFrame: 12 and 24 months
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: William F Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.