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| Name | Class |
|---|---|
| Danone Global Research & Innovation Center | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydration | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal decline | Change in estimated glomerular filtration rate between baseline and 12 months | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urine albumin | Change in 24-hour urine albumin between baseline and 12 months | Baseline and 12 months |
| Rapid renal decline | Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Change in Body Mass Index between baseline and 12 months | Baseline and 12 months |
| Blood pressure | Change in mean arterial blood pressure between baseline and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William F Clark, MD | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28856009 | Background | 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. | |
| 38320097 | Derived | Moist 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Research staff and participants were aware of the randomized group assignment; however, outcome assessors (technicians performing the laboratory measurements for the primary and secondary outcomes) are blinded to the random allocation, and the trial statistician will be blinded to patient allocation for the primary analysis
| Baseline and 12 months |
| Measured creatinine clearance | Change in measured creatinine clearance between baseline and 12 months | Baseline and 12 months |
| Health-related quality of life | Change in health-related quality of life between baseline and 12 months | Baseline and 12 months |
| Copeptin | Change in copeptin between baseline and 12 months | Baseline and 12 months |
| Baseline and 12 months |
| HbA1c | Change in HbA1c between between baseline and 12 months | Baseline and 12 months |
| Long-term renal decline | Change in estimated glomerular filtration rate between baseline and 24 months | Baseline and 24 months |
| Effect of fluid coaching on adherence | Change in urine volume between 12 months and 24-months follow-up | 12 and 24 months |
| 29801012 | Derived | Clark 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. |
| 28403013 | Derived | Roussel R, Velho G, Bankir L. Vasopressin and diabetic nephropathy. Curr Opin Nephrol Hypertens. 2017 Jul;26(4):311-318. doi: 10.1097/MNH.0000000000000335. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |