A Randomised Controlled Trial of Vitamins C and E to Prevent Pre-eclampsia in Type 1 Diabetic Pregnancy: Acronym DAPIT (Diabetes and Pre-eclampsia Intervention Trial) - Exceptional Application for Additional Funding. (360G-Wellcome-083145_Z_07_Z)

The rate of pre-eclampsia in women with type 1 diabetes is 2-4 times higher than in normal pregnancies. Diabetes is associated with antioxidant depletion and increased free radical production. An increasing body of evidence suggests that oxidative stress and endothelial cell activation may be relevant to disease pathogenesis in pre-eclampsia. DAPIT aims is to establish if pregnant women with type 1 diabetes supplemented with vitamins C and E have lower rates of pre-eclampsia and endothelial ac tivation compared with placebo treatment. Funded by The Wellcome Trust, DAPIT is a double blind randomised multicentre placebo-controlled trial that will recruit 756 pregnant women with type 1 diabetes. Women are randomised to daily vitamin C (1000mg) and vitamin E (400IU) or placebo at 8-22 weeks gestation until delivery. At randomisation, 26 and 34 weeks, maternal venous blood is collected to measure markers of endothelial activation, oxidative stress and to assess glycaemic control. The prima ry outcome of DAPIT is incidence of pre-eclampsia. Secondary outcomes include endothelial activation (PAI-1/PAI-2) and birthweight centile. In addition, economic analysis will be carried out to determine if the intervention is cost-effective. To date, 594 women have been randomised and additional funding is required to allow DAPIT to complete the trial.