Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-03-29 @ 12:41 PM
Study NCT ID:
NCT01753466
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Water Intake Trial: Pilot Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour urine volume', 'timeFrame': '6 weeks (baseline and six weeks)', 'description': 'Change in 24-hour urine volume between baseline and six weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '26603245', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24362012', 'type': 'DERIVED', 'citation': 'Clark 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe investigators hypothesize that patients will be able to increase and maintain a higher fluid intake with stable blood chemistry, particularly serum sodium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-80 years\n* Able to provide informed consent and willing to complete follow-up visits.\n* Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2\n* Microalbuminuria \\[albumin to creatinine ratio \\>2.8 mg/mmol (if female) or \\>2.0 mg/mmol if male)\\]\n\nExclusion Criteria:\n\n* Self-reported fluid intake \\>10 cups/day or 24-hr urine volume \\>3L.\n* Enrolled in another randomized controlled trial that could influence the intervention, outcomes or data collection of this trial (or previously enrolled in this trial)\n* Received one or more dialysis treatments in the past month\n* Kidney transplant recipient (or on waiting list)\n* Pregnant or breastfeeding\n* History of kidney stones in past 5 years\n* Less than two years life expectancy\n* Serum sodium \\<130 mEq/L without suitable explanation\n* Serum calcium \\>2.6 mmol/L without suitable explanation\n* Currently taking hydrochlorothiazide \\>25 mg/d, indapamide \\>1.25 mg/d, furosemide \\>40 mg, or metolazone \\>2.5 mg/d\n* Currently taking lithium\n* 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'}, 'identificationModule': {'nctId': 'NCT01753466', 'acronym': 'WIT', 'briefTitle': 'The Water Intake Trial: Pilot Phase', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'The Water Intake Trial: Pilot Phase', 'orgStudyIdInfo': {'id': 'EAU-6607-GD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydration', 'description': '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', 'interventionNames': ['Dietary Supplement: Hydration']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Hydration', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'William F Clark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nephrologist', 'investigatorFullName': 'William Clark', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}