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Marie-Hélène Masse
Julie Ménard
Sheila Sprague

Thanks to all Participating Centers and collaborators for engaging in this research program!

Thanks to the CCCTG for endorsing this research project.


Vitamin C Population Pharmacokinetic Substudy

The objective of this substudy is to ascertain the volume of distribution, clearance, and plasma concentration over a course of 96 hours of intravenous vitamin C 50 mg/kg of weight every 6 hours or matching placebo.

Three centers will participate in this substudy.At these centers, 100 consecutive consenting patients (i.e. distinct consent form) enrolled and randomized to either arm will participate by contributing serial blood samples for plasma vitamin C measurement. Plasma concentrations will be modeled over time using a population PK approach.

Each patient (in either arm) will provide serial blood samples that will be obtained by the bedside nurse or research coordinator at prespecified times for quantification of vitamin C in whole blood. Blood samples will be drawn around the 6th dose (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1h, 2h, 4h and 6h (the 6h level will be immediately prior to the next dose). Therefore, each patient will provide 5 blood samples in addition to those required by the LOVIT protocol.