Chronic Kidney DiseaseWITNCT01766687
Impact of Increased Water Intake in Chronic Kidney Disease
A 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 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… Read more about this study
- Who is it for?
- Ages 18 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
- 822 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jun 2017
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show 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) 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Hydration
- Keywords
- Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline
- 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 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. 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.
Renal decline
Change in estimated glomerular filtration rate between baseline and 12 months
Measured: Baseline and 12 months
Secondary outcomes (5)
24-hour urine albumin
Change in 24-hour urine albumin between baseline and 12 months
Measured: Baseline and 12 months
Rapid renal decline
Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months
Measured: Baseline and 12 months
Measured creatinine clearance
Change in measured creatinine clearance between baseline and 12 months
Measured: Baseline and 12 months
Health-related quality of life
Change in health-related quality of life between baseline and 12 months
Measured: Baseline and 12 months
Copeptin
Change in copeptin between baseline and 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 822 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
- NCT01766687
- Sponsor's protocol ID
- S-London RCT
- Acronym
- WIT
- Status last verified
- Aug 2017
- First submitted
- 9 Jan 2013
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Aug 22;4:2054358117725106. doi: 10.1177/2054358117725106. eCollection 2017.
PubMed 28856009Moist LM. Can Additional Water a Day Keep the Cysts Away, in Patients with Polycystic Kidney Disease? NEJM Evid. 2022 Jan;1(1):EVIDe2100027. doi: 10.1056/EVIDe2100027. Epub 2021 Nov 4.
PubMed 38320097Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.
PubMed 29801012Roussel R, Velho G, Bankir L. Vasopressin and diabetic nephropathy. Curr Opin Nephrol Hypertens. 2017 Jul;26(4):311-318. doi: 10.1097/MNH.0000000000000335.
PubMed 28403013
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01766687
- Acronym / sponsor ID
- WIT / S-London RCT
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, estimated glomerular filtration rate, water intake, fluid intake, renal decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 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
- Apr 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Jan 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration | Experimental | Dietary Supplement: HydrationParticipants 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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
Renal decline
Time frame: Baseline and 12 months
Change in estimated glomerular filtration rate between baseline and 12 months
5 secondary outcomes
24-hour urine albumin
Time frame: Baseline and 12 months
Rapid renal decline
Time frame: Baseline and 12 months
Measured creatinine clearance
Time frame: Baseline and 12 months
Health-related quality of life
Time frame: Baseline and 12 months
Copeptin
Time frame: Baseline and 12 months
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 25 Aug 2017.
- Background: PubMed 28856009Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Aug 22;4:2054358117725106. doi: 10.1177/2054358117725106. eCollection 2017.
- Derived from this study: PubMed 38320097Moist LM. Can Additional Water a Day Keep the Cysts Away, in Patients with Polycystic Kidney Disease? NEJM Evid. 2022 Jan;1(1):EVIDe2100027. doi: 10.1056/EVIDe2100027. Epub 2021 Nov 4.
- Derived from this study: PubMed 29801012Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.
- Derived from this study: PubMed 28403013Roussel R, Velho G, Bankir L. Vasopressin and diabetic nephropathy. Curr Opin Nephrol Hypertens. 2017 Jul;26(4):311-318. doi: 10.1097/MNH.0000000000000335.
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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 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 13 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 25 Aug 2017. 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.
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?
Renal decline (time frame: Baseline and 12 months). 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 NCT01766687, which also lists 4 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 25 Aug 2017.