The Water Intake Trial: Pilot Phase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydration

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

Group Type EXPERIMENTAL

Hydration

Intervention Type DIETARY_SUPPLEMENT

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No