Why we need a clinical trial for vitamin K

Abstract

Vitamin K is given to many babies born in the United Kingdom, but we still do not know if it has substantial hazards. Because the population exposed to vitamin K is very large even quite small hazards would involve many adverse events. It is therefore important to be able to put reasonably close bounds on the potential damage that vitamin K prophylaxis could cause. Past research has not allowed us to do this but a large randomised controlled clinical trial of vitamin K against no vitamin K, enrolling only infants at low risk of haemorrhagic disease, would do so. There is no question that vitamin K is a useful treatment in babies at highest risk of haemorrhagic disease: the question is whether the trend towards use of vitamin K in lower risk babies should be encouraged.