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Completed

NCT Number: NCT01766687

Impact of Increased Water Intake in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Hydration

Dietary Supplement

Primary outcomes

  1. Renal decline

    Time frame: Baseline and 12 months

    Change in estimated glomerular filtration rate between baseline and 12 months

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Official study title

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

Acronym: WIT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2013
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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