Trial record 16 of 511 for:
Open Studies | "Renal Insufficiency, Chronic"
Impact of Increased Water Intake in Chronic Kidney Disease (WIT)
This study is currently recruiting participants.
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
Collaborator:
Danone Research
Information provided by (Responsible Party):
William Clark, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01766687
First received: January 9, 2013
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Dietary Supplement: Hydration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- Renal decline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in estimated glomerular filtration rate between baseline and 12 months
Secondary Outcome Measures:
- albumin to creatinine ratio [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in albumin to creatinine ratio between baseline and 12 months
- Rapid renal decline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months
Other Outcome Measures:
- Body Mass Index [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in Body Mass Index between baseline and 12 months
- Blood pressure [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in mean arterial blood pressure between baseline and 12 months
- Copeptin [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in copeptin between baseline and 12 months
- HbA1c [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Change in HbA1c between between baseline and 12 months
| Estimated Enrollment: | 700 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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 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) 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766687
Contacts
| Contact: William F Clark, MD | 519-685-8500 ext 58361 | william.clark@lhsc.on.ca |
Locations
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4G5 | |
| Principal Investigator: William F Clark, MD | |
Sponsors and Collaborators
Lawson Health Research Institute
Danone Research
Investigators
| Principal Investigator: | William F Clark, MD | London Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | William Clark, Principle Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01766687 History of Changes |
| Other Study ID Numbers: | S-London RCT |
| Study First Received: | January 9, 2013 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by 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 Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 21, 2013