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 |