Chen, Ping
Reed, Greg
Jiang, Joyce
Wang, Yaohui
Sunega, Jean
Dong, Ruochen
Ma, Yan
Esparham, Anna
Ferrell, Ryan
Levine, Mark
Drisko, Jeanne http://orcid.org/0000-0001-7187-3368
Chen, Qi
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetic Evaluation of Intravenous Vitamin C: A Classic Pharmacokinetic Study
https://doi.org/10.1007/s40262-022-01142-1
Funding for this research was provided by:
Thomas Jefferson University (Endowment)
School of Medicine, University of Kansas (Endowment, Cancer Center P30 CA168524)
National Institute of Diabetes and Digestive and Kidney Diseases (Intramural funding)
Article History
Accepted: 4 May 2022
First Online: 25 June 2022
Declarations
:
: Funding for the study was provided by private foundations through both Jefferson Medical Endowment and the University of Kansas Medical Center Endowment. Pharmacokinetics support was provided by the Clinical Pharmacology Shared Resource of the University of Kansas Cancer Center (P30 CA168524). ML was supported by the Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. Study drug was provided at no cost to the study by Mylan Pharmaceutical (Viatris).
: Ping Chen, Greg Reed, Joyce Jiang, Yaohui Wang, Jean Sunega, Ruochen Dong, Yan Ma, Anna Esparham, Ryan Ferrell, Mark Levine, Jeanne Drisko, and Qi Chen declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.
: The study was conducted in compliance with the FDA-approved study protocol (IND number 65,805). Trial oversight was provided by University of Kansas Health System, Kansas Cancer Center Data and Safety Monitoring Board with independent event adjudication. The Clinical Trials website ExternalRef removed study number was NCT01833351.
: The protocol and consent form were approved by the University of Kansas Health System, Institutional Review Board and the Kansas Cancer Center Protocol Review and Management Committee. All study participants were allowed to ask questions about study participation prior to signing the consent form. All signed consent forms are maintained in study files.
: Not applicable.
: Requests for study data will be honored after written request to the corresponding author and pending approval by appropriate oversight bodies.
: Not applicable.
: JD, QC, GR, PC, ML, and JJ participated in trial design, data analysis, and interpretation. All authors were involved in preparation, review, and approval of this article. PC, YW, RD, YM, RF, AE, and JS were involved in sample collection, preparation, and analysis. No other entity or persons, other than the authors, contributed to the writing, review, or approval of the publication. The funders of the study and the pharmaceutical company did not contribute to the design, conduct, or interpretation of data.