Garreto 2016.

Trial name or title	A randomised control trial of vitamin D prophylaxis in the prevention of hypertensive disorders of pregnancy
Methods	Randomised open‐label clinical trial (parallel assignment)
Participants	Women 18 years of age and older, with a confirmed intrauterine pregnancy, less than 16 weeks' gestation and carrying a singleton gestation. Those taking vitamin D supplementation outside of prenatal vitamins are excluded from study participation. Additional exclusion criteria were: known disorder that will affect vitamin D levels (i.e. hyperparathyroidism, mal‐absorption disorder, history of gastric bypass surgery, immunocompromised state, maternal use of immune‐modulators etc.), carrying a fetus with known aneuploidy or anomaly, fetal demise, chronic use of diuretic or cardiac medication therapy including calcium channel blockers.
Interventions	G1: vitamin D prophylaxis: participants will be provided vitamin D 3000 IU daily or vitamin D 4000 IU daily with and without concurrent use of prenatal vitamins, respectively. G2: participants will not receive additional vitamin D in the pregnancy (but prenatal vitamins?)
Outcomes	Maternal Primary Pre‐eclampsia Adverse events: gestational hypertension, eclampsia, toxemia, HELLP syndrome. Secondary Serum levels of 25(OH)D (ng/mL) Infant Primary Preterm birth Low birthweight Secondary Cord blood levels of 25(OH)D (ng/mL) Apgar score Adverse neonatal outcomes: neonatal intensive care unit admission, fetal distress, respiratory distress syndrome, ventilation, neonatal infection, fracture, and neonatal death
Starting date	October 2016
Contact information	Diana J Garretto, MD; (631) 444‐7650; diana.garretto@stonybrookmedicine.edu Malini D Persad, MD MPH; (631) 444‐7650; malini.persad@stonybrookmedicine.edu
Notes	Funding: Stony Brook University Declarations of interest among primary researchers: NA City/country: New York, US