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Effect of Bio-impedance Analysis and Vitamin D vs Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: A Randomized Controlled Trial (FLUID Study) (FLUID Trial)
Phase 2
Waitlist Available
Led By Azim S Gangji, MD MSc FRCPC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Summary
The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Usual care and Vitamin DExperimental Treatment1 Intervention
Vitamin D3
Group II: Bioimpedance and Vitamin DExperimental Treatment1 Intervention
Group III: Bioimpedance and PlaceboExperimental Treatment1 Intervention
Group IV: Usual Care and PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
202 Previous Clinical Trials
26,855 Total Patients Enrolled
Population Health Research InstituteOTHER
164 Previous Clinical Trials
718,444 Total Patients Enrolled
Azim S Gangji, MD MSc FRCPCPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
K S Brimble, MD MSc FRCPCPrincipal InvestigatorSt. Joseph's Healthcare Hamilton