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

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ClinicalTrials.gov Identifier: NCT01766687
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
William Clark, Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Hydration Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research staff and participants were aware of the randomized group assignment; however, outcome assessors (technicians performing the laboratory measurements for the primary and secondary outcomes) are blinded to the random allocation, and the trial statistician will be blinded to patient allocation for the primary analysis
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
Study Start Date : April 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Renal decline [ Time Frame: Baseline and 12 months ]
    Change in estimated glomerular filtration rate between baseline and 12 months


Secondary Outcome Measures :
  1. 24-hour urine albumin [ Time Frame: Baseline and 12 months ]
    Change in 24-hour urine albumin between baseline and 12 months

  2. Rapid renal decline [ Time Frame: Baseline and 12 months ]
    Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months

  3. Measured creatinine clearance [ Time Frame: Baseline and 12 months ]
    Change in measured creatinine clearance between baseline and 12 months

  4. Health-related quality of life [ Time Frame: Baseline and 12 months ]
    Change in health-related quality of life between baseline and 12 months

  5. Copeptin [ Time Frame: Baseline and 12 months ]
    Change in copeptin between baseline and 12 months


Other Outcome Measures:
  1. Body Mass Index [ Time Frame: Baseline and 12 months ]
    Change in Body Mass Index between baseline and 12 months

  2. Blood pressure [ Time Frame: Baseline and 12 months ]
    Change in mean arterial blood pressure between baseline and 12 months

  3. HbA1c [ Time Frame: Baseline and 12 months ]
    Change in HbA1c between between baseline and 12 months

  4. Long-term renal decline [ Time Frame: Baseline and 24 months ]
    Change in estimated glomerular filtration rate between baseline and 24 months

  5. Effect of fluid coaching on adherence [ Time Frame: 12 and 24 months ]
    Change in urine volume between 12 months and 24-months follow-up



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 within past six months (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
  • Patient has GI disease (history of inflammatory bowel disease, Crohns, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766687


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Clark, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01766687     History of Changes
Other Study ID Numbers: S-London RCT
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by William Clark, 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