DAPIT 2004.

Trial name or title	The Diabetes and Pre‐eclampsia Intervention Trial (DAPIT). Clinical Trial Identifier: ISRCTN27214045
Methods
Participants	Inclusion criteria: type 1 diabetes preceding pregnancy; age >= 16 years; between 8 and 22 weeks' gestation; date of last menstrual period certain or ultrasound estimation from 6‐22 weeks of gestational age is available, or both; singleton pregnancy. Exclusion criteria: ingestion of preparations containing vitamin C > 500 mg/day or vitamin E > 200 IU/day; participation in another study which may interfere with DAPIT; participation in DAPIT during a previous pregnancy, where DAPIT trial medication was taken within the last 6 months; any notation of drug abuse: cocaine, LSD, heroin, marijuana, inhaled solvents/gases; warfarin therapy. Planned sample size: 945 women.
Interventions	Daily 1000 mg vitamin C and 400 IU vitamin E or placebo.
Outcomes	Primary outcome: incidence of pre‐eclampsia. Secondary outcomes: endothelial activation, birthweight centile.
Starting date	April 2003.
Contact information	Dr David R McCance Consultant Physician/Honorary Senior Lecturer, Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast BT12 6BA. E‐mail: david.mccance@royalhospitals.n‐i.nhs.uk
Notes