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The VICTAS Trial: Designed to Fail
|Box 1 Rules for individual clinical studies of nutrient effects.||Box 2 Rules for study inclusion in systematic reviews and meta-analyses.|
|1. Basal nutrient status must be measured, used as an inclusion criterion for entry into study, and recorded in the report of the trial.
2. The intervention (i.e., change in nutrient exposure or intake) must be large enough to change nutrient status and must be quantified by suitable analyses.
3. The change in nutrient status produced in those enrolled in the trials must be measured and recorded in the report of the trial.
4. The hypothesis to be tested must be that a change in nutrient status (not just a change in diet) produces the sought-for effect.
5. Co-nutrient status must be optimized in order to ensure that the test nutrient is the only nutrition related, limiting factor in the response.
|1. The individual studies selected for review or meta-analysis must have met the criteria listed in Box 1 for nutrient trials.
2. All included studies must have started from the same or similar basal nutrient status values.
3. All included studies must use the same or closely similar doses.
4. All included studies must have used the same chemical form of the nutrient and, if foods are used as the vehicle for the test nutrient, all studies must have employed the same food matrix.
5. All included studies must have the same co-nutrient status.
6. All included studies must have had approximately equal periods of exposure to the altered intake.
The VICTAS Trial  satisfied none of these 5 rules for conducting nutrient research.
Recent research has shown the importance of vitamin C in sepsis and other acute life-threatening illnesses. Vitamin C has a multitude of essential for life effects within the human body, and due to its short half-life, is often the rate limiting factor in these biochemical processes. It is the primary extracellular antioxidant, and is important for scavenging damaging electron radicals. At very high levels it is involved in redox regulation, is a pro-oxidant, and can cause DNA and/or protein damage. This is useful in the treatment of cancer. It is an essential co-factor in the synthesis of catecholamines, vasopressin, steroids, neuropeptides and some neurotransmitters. It is also essential in the synthesis of collagen and elastin -- which are important molecules throughout the body, including in arteries and joints. Vitamin C is also important for epigenomic regulation of genes and is necessary for many cell types of the adaptive immune system. These biochemical functions are essential for improved immune cell function, endothelial cell function, hemodynamics (circulatory function), and wound healing.
Stress, including cold temperatures, toxins, infections, and trauma greatly increase the cellular demand for vitamin C, and disrupt the body's ability to recycle oxidized vitamin C (dehydroascorbic acid or DHAA) back into the reduced form of vitamin C (ascorbic acid). Vitamin C has a short half life in the body (minutes to hours). In 2008, the prestigious journal Cell published the discovery that the red blood cells of humans (and other mammals unable to produce vitamin C) express a large number of GLUT1 transporters - more GLUT1 than on any other human cell type.  These GLUT1 transporters are apparently misnamed, as they might more properly be called DHAA1 transporters. The human RBC GLUT1 transporter is co-expressed with the protein stomatin which switches it into a DHAA transporter rather than a glucose transporter.  The result is 20-30 trillion red blood cells in healthy humans circulating through miles of blood vessels "soaking up" DHAA and - if adequate levels of the selenoprotein glutathione peroxidase are present in the red blood cells - reducing the DHAA back to AA and sending it back into the blood. A similar recycling system is present in the brain between astrocytes and tanycytes.  This supports the concept that keeping the blood, vasculature, and brain bathed in adequate ascorbic acid is important.
Humans in acute distress from toxins, viruses, and bacteria have been successfully treated with high dose vitamin C injections for over 70 years. Recent studies have shown a synergistic benefit to endothelial cells when vitamin C and cortisol are injected into blood vessels simultaneously. Decades of experience have underscored the importance of early intervention, and increasing the dose and duration as needed to neutralize the acidosis and/or toxins. [27-53]
Below is a graph courtesy of Dr. Paul E Marik of an ICU patient's c-reactive protein level (biomarker of inflammation) during 3g IVC and a corticosteroid co-administration every 6 hours for 96 hours, stopping the treatment, and then resuming the treatment. Continued vitamin C treatment until full recovery, tapering from IV to oral administration as the patient recovers, is important. It takes ongoing administration of vitamin C to achieve and maintain the tissue saturation levels needed to treat sepsis and septic shock.
Is 70 years of successful treatments to thousands of patients insufficient evidence? If more studies are needed, who will put the 350-700 mg/kg/day IVC dose to the test without the dangerous and artificial 96 hour limitation?
I would like to acknowledge Benjamin Rakotoambinina, MD, PhD, professor of Physiology at the University of Antananarivo, Madagascar in collaboration with Laurent Hiffler, MD of the Cellular Nutrition Research Group for their critical review and feedback; and Drs. Robert G. Smith and Andrew Saul for their critical review and editorial support.
(Michael E. Passwater, son of author and columnist Dr. Richard Passwater, is certified by the American Society for Clinical Pathology as a medical technologist, a specialist in immunohematology, and is a diplomate in laboratory management. He has worked in clinical laboratories for 28 years, and has previously written â€œDo the Math: "MATH+" Saves Livesâ€ published by the Orthomolecular Medicine News Service http://orthomolecular.org/resources/omns/v16n55.shtml ).
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