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Table 1 Trial registration data

From: Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol

Data category Information
Primary registration and trial identification number ClinicalTrials.gov NCT02626299
Date of registration December 8, 2015
Secondary identifying numbers R01 HD083292; IND 129482; IRB STUDY00003455
Source of monetary or material support National Institute of Child Health and Human Development
Primary sponsor University of Kansas Medical Center
Secondary sponsor/Collaborators University of Cincinnati
Ohio State University
Nationwide Children’s Hospital
Contact for public queries Beth Kerling, MS RD (ekerling@kumc.edu)
Contact for scientific queries Susan Carlson, PhD (scarlson@kumc.edu)
Public title Assessment of DHA On Reducing Early preterm Birth (ADORE) Trial
Scientific title Docosahexaenoic Acid Supplementation in Pregnancy to Reduce Early Preterm Birth
Countries of recruitment United States
Health conditions or problem studied Preterm birth
Interventions Active treatment: 1,000 mg DHA per day
Standard of care: 200 mg DHA per day
Key inclusion and exclusion criteria Ages eligible for study: ≥ 18 years
Genders eligible for study: female
Accepts healthy volunteers: yes
Inclusion criteria: pregnant female ≥ 18 years; 12–20 weeks of gestation, agree to consume study capsules; available by telephone
Exclusion criteria: multiple gestation, unwilling to discontinue use of another prenatal supplement with DHA, allergy to any component of DHA product (including algae), soybean oil or corn oil
Study type Interventional
Allocation: randomized
Endpoint classification: safety/efficacy study
Intervention Model: parallel assignment
Masking: double blind
Primary purpose: prevention
Phase III
Date of first enrollment June 8, 2016
Recruitment status Active recruitment
Primary outcome Occurrence of early preterm birth
Key secondary outcomes Efficacy analysis for subset populations
Effect of DHA on inflammation
Safety evaluation