Impact of Increased Water Intake in Chronic Kidney Disease (WIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
William Clark, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01766687
First received: January 9, 2013
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

The investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. The investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. The investigators hypothesize that increased water intake will slow renal decline.


Condition Intervention Phase
Chronic Kidney Disease
Dietary Supplement: Hydration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Renal decline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in estimated glomerular filtration rate between baseline and 12 months


Secondary Outcome Measures:
  • albumin to creatinine ratio [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in albumin to creatinine ratio between baseline and 12 months

  • Rapid renal decline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months


Other Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in Body Mass Index between baseline and 12 months

  • Blood pressure [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in mean arterial blood pressure between baseline and 12 months

  • Copeptin [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in copeptin between baseline and 12 months

  • HbA1c [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in HbA1c between between baseline and 12 months


Estimated Enrollment: 700
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydration
Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual consumed beverages, for 12 months.
Dietary Supplement: Hydration
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 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
  • Trace protein or greater (Albustix) or urine albumin/creatinine ratio >2.8 mg/mmol (if female) or >2.0 mg/mmol (if male) from a random spot urine sample

Exclusion Criteria:

  • Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.
  • Enrolled in another 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) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766687

Contacts
Contact: William F Clark, MD 519-685-8500 ext 58361 william.clark@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Principal Investigator: William F Clark, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Danone Research
Investigators
Principal Investigator: William F Clark, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: William Clark, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01766687     History of Changes
Other Study ID Numbers: S-London RCT
Study First Received: January 9, 2013
Last Updated: April 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Chronic Kidney Disease
estimated glomerular filtration rate
water intake
fluid intake
renal decline

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 21, 2014