Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
Status: Completed
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
• Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
• Available by telephone
• Able to speak and read in either English or Spanish language
Locations
United States
Kansas
University of Kansas Medical Center
Kansas City
Ohio
University of Cincinnati
Cincinnati
Ohio State University
Columbus
Time Frame
Start Date: 2016-06-08
Completion Date: 2020-10-05
Participants
Target number of participants: 1100
Treatments
Placebo_comparator: 200 mg/day DHA
Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.
Experimental: 1000 mg/day DHA
The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.
Authors
Sponsors
Collaborators: Nationwide Children's Hospital, University of Cincinnati, Ohio State University
Leads: University of Kansas Medical Center