Researchers to study vitamin C as treatment for septic lung injury
Researchers from Virginia Commonwealth University will lead a multicenter $3.2 million National Institutes of Health grant to study whether high doses of vitamin C can effectively treat septic lung injury resulting from infection. The VCU team will collaborate with colleagues from Wake Forest, University of Virginia and Emory to begin phase 2 clinical trials.
Sepsis is caused by the immune system’s response to a serious infection and is characterized by systemic inflammation, organ dysfunction and organ failure. Four out of 10 septic patients develop lung injury. Despite modern advances in critical care, one-third to half of all severely septic patients die, resulting in millions of deaths globally each year.
“When patients are septic, their bodies lose the ability to control blood pressure. We wanted to see if vitamin C could help to control the pressure,” said Alpha (Berry) Fowler III, M.D., chair of the Division of Pulmonary Disease and Critical Care Medicine and professor of internal medicine in the VCU School of Medicine. “We found that in preclinical studies, vitamin C prevented the inflammatory response in sepsis. We continued our work with a small clinical trial to study the safety of giving high doses of vitamin C to septic patients. We did not see any side effects from the vitamin C.”
The small phase-one safety trial showed that patients receiving the high doses of vitamin C, infused intravenously, had significantly improved outcomes with lower rates of mortality, but larger studies are needed. In July, the investigators were awarded the NIH’s National Heart, Lung and Blood Institute grant to continue with a phase-two, or proof of concept, trial. This trial, which will begin entering patients early next year, will evaluate vitamin C in the patient population and determine efficacy.
“We are looking to test vitamin C as an intervention for early lung injury due to sepsis. Our goal is to enroll about 170 patients among the four research sites in the next two to three years,” Fowler said. “This research is important because the current standard of care doesn’t work and it is expensive. We’re hopeful that vitamin C might be an effective intervention that will save lives.”
Fowler credits the VCU Center for Clinical and Translational Research for helping to secure the NIH grant. The CCTR provides the necessary infrastructure and resources for interdisciplinary human health research at VCU. Through the Research Incubator, Biomedical Informatics, Clinical Research Services and other service cores, the CCTR offers grant writing and biostatistics support, identifies funding sources, conducts mock study sections, provides data resources and management as well as administrative support for clinical research activities.
“Using the expertise and support of the CCTR, I was able to turn a basic scientific idea into a powerful grant proposal that was ultimately funded,” Fowler said. “From the grant writer, Bonnie Quearry, to the biostatistician, Leroy Thacker, the CCTR staff worked with me to make the grant better, stronger. I have been the beneficiary of an institution full of advanced thinkers and at a university that has a full commitment to translational research.”