The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial
Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM
Canadian journal of kidney health and disease · 6 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2017-01-01 · Can J Kidney Health Dis · vol. 4 · p. 2054358117725106
- Publisher
- SAGE Publishing
- Cited
- 16 citations · more than 72% of similar papers · 0.8× the field average
- References
- 82 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Sodium Intake and Health · Electrolyte and hormonal disorders · Chronic Kidney Disease and Diabetes
- Keywords
- Medicine, Renal function, Kidney disease, Creatinine, Randomized controlled trial, Randomization, Urine osmolality, Microalbuminuria, Internal medicine, Urology, Urine specific gravity, Urinalysis, Urine
8 authors
From CA
- William F. Clark · correspondingVictoria Hospital
- Shih‐Han Susan HuangVictoria Hospital
- Amit X. GargVictoria Hospital
- Kerri GalloVictoria Hospital
- Andrew A. HouseUniversity Hospital
- Louise M. MOISTVictoria Hospital
Abstract
Background
In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown.
Objective
To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease.
Design
Parallel-group randomized controlled trial.
Setting
Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017.
Participants
Adults (n = 631) with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m2) and microalbuminuria.
Intervention
The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight), over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time.
Measures
Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet.
Primary outcome
The between-group change in eGFR from baseline (prerandomization) to 12 months after randomization.
Secondary outcomes
Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation), and health-related quality of life.
Planned analysis
The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using linear regression. Supplementary analyses will examine alternative definitions of eGFR change, including annual percentage change, rate of decline, and rapid decline (a P value <0.05 will be interpreted as statistically significant if there is concordance with the primary outcome).
Trial registration
This randomized controlled trial has been registered at www.clinicaltrials.gov; government identifier: NCT01766687.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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