Clinical trial NCT02626299: Assessment of DHA On Reducing Early Preterm Birth
Official title: Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Keywords: Preterm birth
Early preterm birth
Very low birth weight
Low birth weight
Pregnancy outcome
Docosahexaenoic acid (DHA)
Randomized cliinical trial
Superiority trial
Adaptive design
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: Ohio State University
name: Nationwide Children's Hospital
First posted: 2015-12-10
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed description: Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.

Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.

This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Expecting multiple infants
* Gestational age at baseline \<12 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day
* Women with allergy to any component of DHA product (including algae), soybean oil or corn oil

Primary outcomes:
measure: Occurrence of Early Preterm Birth (<34 weeks gestation)
timeFrame: Baseline to 34 Weeks
measure: Occurrence of Early Preterm Birth (<34 weeks gestation)
timeFrame: Baseline to 34 weeks
measure: Maternal and infant adverse and serious adverse events
timeFrame: Enrollment to 30 days past last birth
Secondary outcomes:
measure: Very low birth weight
timeFrame: At birth
measure: Low birth weight
timeFrame: birth
measure: Maternal and infant DHA status
timeFrame: birth
measure: Gestational age
timeFrame: birth
measure: Birth weight
timeFrame: birth
measure: Length and head circumference
timeFrame: birth
measure: Preterm birth (<37 weeks)
timeFrame: birth
measure: Preterm birth (<37 weeks)
timeFrame: birth
measure: Pre-eclampsia
timeFrame: 12-20 weeks gestation through birth at an average of 40 weeks
measure: Pre-eclampsia
timeFrame: 12-20 weeks gestation through birth at an average of 40 weeks
measure: Gestational diabetes
timeFrame: 12-20 weeks gestation through birth at an average of 40 weeks
measure: Gestational diabetes
timeFrame: 12-20 weeks gestation through birth at an average of 40 weeks
measure: Cesarean section
timeFrame: birth
measure: Cesarean section
timeFrame: birth
measure: Spontaneous labor
timeFrame: birth
measure: Spontaneous labor
timeFrame: birth
measure: Admissiion of neonate to a neonatal intensive care unit
timeFrame: birth
measure: Admissiion of neonate to a neonatal intensive care unit
timeFrame: birth
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: University of Kansas Medical Center
name: Susan E. Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368.
citation: Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun.
citation: Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5.