Carlson 2017 ADORE.

Trial name or title	ADORE
Methods	RCT (multi‐centre, adaptive design, 3 arms): NCT02626299
Participants	Recruitment target: 1200 women. Inclusion criteria: women ≥ 18 years; 12–20 weeks of gestation; agree to consume study capsules and a typical prenatal supplement of 200 mg CHA; and available by telephone. Exclusion criteria: expecting multiple infants; gestational age at baseline < 12 weeks or > 20 weeks; unable or unwilling to agree to consume capsules until birth; unwilling to discontinue use of another prenatal supplement with DHA; and with allergy to any component of DHA product (including algae), soybean oil or corn oil. Setting: Kansas, USA.
Interventions	Intervention group DHA supplements (800 mg/day), administered in 2 400 mg capsules, plus 1 200 mg/capsule per day of DHA that is a common amount in prenatal vitamins. Control group Standard care (200 mg/day of DHA) administered in 2 capsules (masked) containing half soybean oil and half corn oil equalling 800 mg. the soybean and corn oil combination does not contain DHA.
Outcomes	Primary outcome: early preterm birth < 34 weeks (baseline to 34 weeks). Other outcomes: change in plasmal soluble(s) RAGE concentration (baseline to 34 weeks); and adverse events (34 weeks).
Starting date	8 June 2016
Contact information	Dr Susan Carlson, University of Kansas Medical Center, USA, E‐mail: scarlson@kumc.edu
Notes	Funding and collaborators: NICHD R01 HD083292, University of Kansas Medical Center, University of Cincinnati, Ohia State University, Nationwide Children's Hospital.