Ethical concerns with not treating overt vitamin C deficiency
dyspnea, fatigue, scurvy, edema, chest pain, irritability
VITAMIN C DEFICIENCY, SCURVY, SCURVY, EDEMA, DISEASE
A particular ethical concern with the LOVIT trial is that patients with severe vitamin C deficiency were not treated. In the trial protocol [Scurvy is usually associated with vitamin C levels below 0.2 mg/dl, which is 11 µM in current units. However, 11 µM should not be interpreted as a definitive level below which scurvy symptoms start to appear. For example, Hodges commented in the report of an empirical scurvy trial that “a distressing feature is the lack of precision of serum ascorbic acid levels. According to most authorities, deficiency appears after the serum level has fallen below 0.2 mg/100 ml, yet several men in these studies had obvious scurvy at a time when their serum levels were above this value” [Emergence of scurvy symptoms has a much closer correlation with the total body pool of vitamin C than with plasma vitamin C level. Hodges stated that “… a comparison between plasma levels of ascorbate and pool sizes showed a very poor correlation… it is fair to say that scurvy appeared when the [vitamin C] body pool size fell below 300 mg” [A more recent study on vitamin C deprivation found that at the lowest point of depletion, with vitamin C levels of about 10 µM, mild but consistent feelings of fatigue and/or irritability were elicited [Experimental vitamin C deprivation in healthy volunteers has led to dyspnea, chest pain, edema, fatigue and reduced autonomic reflexes [In the LOVIT trial, 25% of patients had baseline vitamin C levels less than 5.37 µM (figure 3 in [Given that scurvy is a serious and potentially life-threatening disease it seems ethically inappropriate to randomize half the patients who have vitamin C levels <5.37 µM to a placebo group which is not administered vitamin C. There is no discussion in the LOVIT trial protocol or trial report [