Skip to main content
OpenTrials
Completed

NCT Number: NCT01753466

The Water Intake Trial: Pilot Phase

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydration

Dietary Supplement

Primary outcomes

  1. 24-hour urine volume

    Time frame: 6 weeks (baseline and six weeks)

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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Acronym: WIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.