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Clinical Trials/NCT01766687
NCT01766687
Completed
N/A

A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease

Lawson Health Research Institute1 site in 1 country822 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Lawson Health Research Institute
Enrollment
822
Locations
1
Primary Endpoint
Renal decline
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Clark

Principle Investigator

Lawson Health Research Institute

Eligibility 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

Outcomes

Primary Outcomes

Renal decline

Time Frame: Baseline and 12 months

Change in estimated glomerular filtration rate between baseline and 12 months

Secondary Outcomes

  • Rapid renal decline(Baseline and 12 months)
  • Copeptin(Baseline and 12 months)
  • 24-hour urine albumin(Baseline and 12 months)
  • Measured creatinine clearance(Baseline and 12 months)
  • Health-related quality of life(Baseline and 12 months)

Study Sites (1)

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