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The Water Intake Trial: Pilot Phase (WIT)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
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

Eligibility Criteria

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

Inclusion Criteria:

  • Age 30-80 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
  • Microalbuminuria [albumin to creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol if male)]

Exclusion Criteria:

  • Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.
  • Enrolled in another randomized controlled 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 recipient (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 or more) 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

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 who are randomized to the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day, depending on sex and weight, in addition to usual consumed beverages, for 6 weeks

Outcomes

Primary Outcome Measures

24-hour urine volume
Change in 24-hour urine volume between baseline and six weeks

Secondary Outcome Measures

Full Information

First Posted
November 9, 2012
Last Updated
April 19, 2013
Sponsor
Lawson Health Research Institute
Collaborators
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT01753466
Brief Title
The Water Intake Trial: Pilot Phase
Acronym
WIT
Official Title
The Water Intake Trial: Pilot Phase
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (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
No

5. Study Description

Brief Summary
The investigators are conducting a six-week randomized controlled pilot trial to assess the feasibility and safety of increased water intake in patients with chronic kidney disease.The investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in a 2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized to the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks. Participants in the control group will be advised to consume their usual amount of fluid. The investigators hypothesize that patients will be able to increase and maintain a higher fluid intake with stable blood chemistry, particularly serum sodium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydration
Arm Type
Experimental
Arm Description
Participants who are randomized to the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day, depending on sex and weight, in addition to usual consumed beverages, for 6 weeks
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydration
Primary Outcome Measure Information:
Title
24-hour urine volume
Description
Change in 24-hour urine volume between baseline and six weeks
Time Frame
6 weeks (baseline and six weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30-80 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 Microalbuminuria [albumin to creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol if male)] Exclusion Criteria: Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L. Enrolled in another randomized controlled 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 recipient (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 or more) 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
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
26603245
Citation
Sontrop JM, Huang SH, Garg AX, Moist L, House AA, Gallo K, Clark WF. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial. BMJ Open. 2015 Nov 24;5(11):e008634. doi: 10.1136/bmjopen-2015-008634.
Results Reference
derived
PubMed Identifier
24362012
Citation
Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Weir MA, Garg AX. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial. BMJ Open. 2013 Dec 20;3(12):e003666. doi: 10.1136/bmjopen-2013-003666.
Results Reference
derived

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The Water Intake Trial: Pilot Phase

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