Text Size

The Water Intake Trial: Pilot Phase (WIT)

This study has been completed.
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
William Clark, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01753466
First received: November 9, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Dietary Supplement: Hydration
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Water Intake Trial: Pilot Phase

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 24-hour urine volume [ Time Frame: 6 weeks (baseline and six weeks) ] [ Designated as safety issue: No ]
    Change in 24-hour urine volume between baseline and six weeks


Enrollment: 33
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydration
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
 Dietary Supplement: Hydration
No Intervention: Control

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753466

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Danone Research
Investigators
Principal Investigator: William F Clark, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: William Clark, Nephrologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01753466     History of Changes
Other Study ID Numbers: EAU-6607-GD
Study First Received: November 9, 2012
Last Updated: April 19, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013