Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)

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

Start

2010-08-01

Primary completion

2016-05-15

Completion

2016-11-30

Outcome

Missed primary endpoint

paper BIA-guided volume management had a modest impact on volume status with no effect on the change in LV mass. PMID 34656640 ↗

paper Vitamin D supplementation increased serum vitamin D concentration but had no effect on LV mass. PMID 34656640 ↗

Publications

• Brimble KS, Ganame J, Margetts P, Jain A, Perl J, Walsh M, Bosch J, Yusuf S, Beshay S, Su W, Zimmerman D, Lee SF, Gangji AS. Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2022 Jun;79(6):820-831. doi: 10.1053/j.ajkd.2021.08.022. Epub 2021 Oct 14.
• Su WS, Gangji AS, Margetts PM, Bosch J, Yusuf S, Clase CM, Ganame J, Noseworthy M, Lonn E, Jain AK, McCormick B, Brimble KS. The fluid study protocol: a randomized controlled study on the effects of bioimpedance analysis and vitamin D on left ventricular mass in peritoneal dialysis patients. Perit Dial Int. 2011 Sep-Oct;31(5):529-36. doi: 10.3747/pdi.2010.00232. Epub 2011 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholecalciferol	Other / unclassified	10000 iu	Oral
Subject	Vitamin D	Other / unclassified	10000 iu	Oral

Indications

No indication recorded.