Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT01753466
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2012-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Water Intake Trial: Pilot Phase
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
The Water Intake Trial: Pilot Phase
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIT
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: