The Water Intake Trial: Pilot Phase

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Hydration

• Registration Number: NCT01753466
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydration	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

Primary Outcome Measures

Name	Time	Method
24-hour urine volume	6 weeks (baseline and six weeks)	Change in 24-hour urine volume between baseline and six weeks

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada