Chronic Kidney DiseasePhase 3WITNCT01753466
The Water Intake Trial: Pilot Phase
A Phase 3 study testing Hydration in people with Chronic Kidney Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)]
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Hydration
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Hydration | Experimental | 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 Receives: Dietary Supplement: Hydration |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine volume
Change in 24-hour urine volume between baseline and six weeks
Measured: 6 weeks (baseline and six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, William Clark, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- William F Clark, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753466
- Sponsor's protocol ID
- EAU-6607-GD
- Acronym
- WIT
- Status last verified
- Apr 2013
- First submitted
- 9 Nov 2012
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sontrop JM, Huang SH, Garg AX, Moist L, House AA, Gallo K, Clark WF. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial. BMJ Open. 2015 Nov 24;5(11):e008634. doi: 10.1136/bmjopen-2015-008634.
PubMed 26603245Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Weir MA, Garg AX. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial. BMJ Open. 2013 Dec 20;3(12):e003666. doi: 10.1136/bmjopen-2013-003666.
PubMed 24362012
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Water Intake Trial: Pilot Phase
- ClinicalTrials.gov ID
- NCT01753466
- Acronym / sponsor ID
- WIT / EAU-6607-GD
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration | Experimental | Dietary Supplement: HydrationParticipants 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 |
| Control | No intervention | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)]
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration | Dietary supplement | Hydration |
Primary outcome
24-hour urine volume
Time frame: 6 weeks (baseline and six weeks)
Change in 24-hour urine volume between baseline and six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Derived from this study: PubMed 26603245Sontrop JM, Huang SH, Garg AX, Moist L, House AA, Gallo K, Clark WF. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial. BMJ Open. 2015 Nov 24;5(11):e008634. doi: 10.1136/bmjopen-2015-008634.
- Derived from this study: PubMed 24362012Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Weir MA, Garg AX. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial. BMJ Open. 2013 Dec 20;3(12):e003666. doi: 10.1136/bmjopen-2013-003666.
Related trials for Chronic Kidney Disease
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William F Clark, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydration in people with Chronic Kidney Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine volume (time frame: 6 weeks (baseline and six weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.