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WIT: The Water Intake Trial: Pilot Phase

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01753466
Collaborator
Danone Research (Industry)
33
Enrollment
1
Location
2
Arms
6
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Hydration
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Water Intake Trial: Pilot Phase
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 24-hour urine volume [6 weeks (baseline and six weeks)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
William Clark, Nephrologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01753466
Other Study ID Numbers:
  • EAU-6607-GD
First Posted:
Dec 20, 2012
Last Update Posted:
Apr 22, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic

Study Results

No Results Posted as of Apr 22, 2013