NCT01753466

The Water Intake Trial: Pilot Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydration

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-20
• Last updated: 2013-04-22

Locations

1 site across 1 country: Canada