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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hydration
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hydration

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Renal decline
Change in estimated glomerular filtration rate between baseline and 12 months

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2013
Last Updated
August 24, 2017
Sponsor
Lawson Health Research Institute
Collaborators
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT01766687
Brief Title
Impact of Increased Water Intake in Chronic Kidney Disease
Acronym
WIT
Official Title
A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Danone Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research staff and participants were aware of the randomized group assignment; however, outcome assessors (technicians performing the laboratory measurements for the primary and secondary outcomes) are blinded to the random allocation, and the trial statistician will be blinded to patient allocation for the primary analysis
Allocation
Randomized
Enrollment
822 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydration
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydration
Primary Outcome Measure Information:
Title
Renal decline
Description
Change in estimated glomerular filtration rate between baseline and 12 months
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
24-hour urine albumin
Description
Change in 24-hour urine albumin between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Rapid renal decline
Description
Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Measured creatinine clearance
Description
Change in measured creatinine clearance between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Health-related quality of life
Description
Change in health-related quality of life between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Copeptin
Description
Change in copeptin between baseline and 12 months
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
Change in Body Mass Index between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Blood pressure
Description
Change in mean arterial blood pressure between baseline and 12 months
Time Frame
Baseline and 12 months
Title
HbA1c
Description
Change in HbA1c between between baseline and 12 months
Time Frame
Baseline and 12 months
Title
Long-term renal decline
Description
Change in estimated glomerular filtration rate between baseline and 24 months
Time Frame
Baseline and 24 months
Title
Effect of fluid coaching on adherence
Description
Change in urine volume between 12 months and 24-months follow-up
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William F Clark, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28856009
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.
Results Reference
background
PubMed Identifier
29801012
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.
Results Reference
derived
PubMed Identifier
28403013
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.
Results Reference
derived

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Impact of Increased Water Intake in Chronic Kidney Disease

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