The Water Intake Trial: Pilot Phase

Chronic Kidney Disease Clinical Trial

— WIT  

Official title:

The Water Intake Trial: Pilot Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753466
• Other study ID #: EAU-6607-GD
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2012
• Last updated: April 19, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Hydration

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Danone Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour urine volume	Change in 24-hour urine volume between baseline and six weeks	6 weeks (baseline and six weeks)	No