The Water Intake Trial: Pilot Phase

NCT01753466 | Completed Phase 3

• 1 other identifier: EAU-6607-GD
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 24-hour urine volume

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

  6 weeks (baseline and six weeks)

Study Arms (2)

Hydration

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Hydration DIETARY_SUPPLEMENT

Hydration

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[albumin to creatinine ratio \>2.8 mg/mmol (if female) or \>2.0 mg/mmol if male)\]

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Related Publications (2)

• Sontrop JM, Huang SH, Garg AX, Moist L, House AA, Gallo K, Clark WF. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial. BMJ Open. 2015 Nov 24;5(11):e008634. doi: 10.1136/bmjopen-2015-008634.

  PMID: 26603245 DERIVED

• Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Weir MA, Garg AX. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial. BMJ Open. 2013 Dec 20;3(12):e003666. doi: 10.1136/bmjopen-2013-003666.

  PMID: 24362012 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William F Clark, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: December 20, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

CA (1)