12/20/2023 0 Comments Lead poisoning antidoteThe study will be performed in the Pediatric Environmental Health Center of Children's Hospital Boston. The d-penicillamine product will be a newly developed, IND-approved liquid formulation. We propose to evaluate, in a Phase II/III randomized, placebo-controlled clinical trial, the effectiveness of d-penicillamine in 50 children aged 6 months to 16 years with blood lead levels 15-25 mcg/dl. Several studies have suggested that d-penicillamine is both safe and effective in the treatment of low-level lead poisoning. ![]() d-Penicillamine is a lead chelator that has been used off-label for almost 4 decades. For children with blood lead levels less than 45 mcg/dl treatment is fraught with difficulties including inconsistent recommendations by clinical experts, lack of proven benefit of chelation and the absence of a chelating agent approved for use in this range. Approved chelating agents for severe plumbism are CaNa2EDTA and succimer. Currently, chelation therapy is uniformly recommended only for children with severe lead poisoning (blood lead > 45 mcg/dl). Despite these well-defined toxicities, treatments for childhood lead poisoning have been inadequate. Non-neurodevelopmental consequences of lead poisoning include impairment of heme synthesis, reduction in 1- hydroxylation of 25(OH) - cholecalciferol (the Vitamin D precursor) and renal injury that results in microproteniuria, an increased risk of hypertension and a greater likelihood of renal failure in adulthood. Lead poisoning in children is unequivocally harmful, producing the neurodevelopmental consequences of cognitive losses, attentional difficulties and behavioral disturbances, including antisocial or delinquent tendencies. Why Should I Register and Submit Results?Īpproximately 300,000 children in the US have elevated blood lead levels (10 mcg/dl or greater).
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