Assessment of DHA On Reducing Early Preterm Birth

Preterm Birth Clinical Trial

— ADORE  

Official title:

Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626299
• Other study ID #: STUDY00003455
• Status: Completed
• Phase: Phase 3
• Start date: June 8, 2016
• Est. completion date: October 5, 2020

Study information

• Verified date: March 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Docosahexaenoic acid - 800mg/day
All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
• Docosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.

Other:
• Placebo
Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Nationwide Children's Hospital, Ohio State University, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Early Preterm Birth (<34 weeks gestation)	Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose	Baseline to 34 Weeks
Primary	Occurrence of Early Preterm Birth (<34 weeks gestation)	Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)	Baseline to 34 weeks
Primary	Maternal and infant adverse and serious adverse events	Bayesian posterior mean and 95% credible interval by dose	Enrollment to 30 days past last birth
Secondary	Very low birth weight	Bayesian posterior mean and 95% credible interval <1500 grams by dose	At birth
Secondary	Low birth weight	Bayesian posterior mean and 95% credible interval <2500 grams by dose	birth
Secondary	Maternal and infant DHA status	Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose	birth
Secondary	Gestational age	Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose	birth
Secondary	Birth weight	Bayesian posterior mean and 95% credible interval in grams by dose	birth
Secondary	Length and head circumference	Bayesian posterior mean and 95% credible interval in centimeters by dose	birth
Secondary	Preterm birth (<37 weeks)	Bayesian posterior mean and 95% credible interval in weeks by dose	birth
Secondary	Preterm birth (<37 weeks)	Number of pregnancies ending in preterm birth by dose	birth
Secondary	Pre-eclampsia	Bayesian posterior mean and 95% credible interval	12-20 weeks gestation through birth at an average of 40 weeks
Secondary	Pre-eclampsia	Number of patients with pre-eclampsia by dose	12-20 weeks gestation through birth at an average of 40 weeks
Secondary	Gestational diabetes	Bayesian posterior mean and 95% credible interval by dose	12-20 weeks gestation through birth at an average of 40 weeks
Secondary	Gestational diabetes	Number of patients with gestational diabetes by dose	12-20 weeks gestation through birth at an average of 40 weeks
Secondary	Cesarean section	Bayesian posterior mean and 95% credible interval by dose	birth
Secondary	Cesarean section	Number of patients with c-section by dose	birth
Secondary	Spontaneous labor	Bayesian posterior mean and 95% credible interval by dose	birth
Secondary	Spontaneous labor	Number of patients with spontaneous labor by dose	birth
Secondary	Admissiion of neonate to a neonatal intensive care unit	Bayesian posterior mean and 95% credible interval by dose	birth
Secondary	Admissiion of neonate to a neonatal intensive care unit	Number of neonates admited to a neonatal intensive care unit by dose	birth