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The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial
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.
Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications. This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Population Health Research Institute - McMaster University
Hamilton, Ontario, Canada
Start Date
August 1, 2010
Primary Completion Date
May 15, 2016
Completion Date
November 30, 2016
Last Updated
May 18, 2025
74
ACTUAL participants
Bioimpedance and Vitamin D
DRUG
Usual care and placebo
DRUG
Usual care and Vitamin D
DRUG
Bioimpedance and Placebo
DEVICE
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Data Source & Attribution
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