Assessment of DHA On Reducing Early Preterm Birth

University of Kansas Medical Center1,100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,100

Conditions

Preterm Birth

Interventions

Docosahexaenoic acid - 800mg/dayDRUG

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/dayDRUG

The control group will receive 1-capsule containing 200 mg DHA/d.

PlaceboOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline to 34 Weeks

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)

Time frame: Baseline to 34 weeks

Maternal and infant adverse and serious adverse events

Bayesian posterior mean and 95% credible interval by dose

Time frame: Enrollment to 30 days past last birth

Secondary Outcomes

Very low birth weight

Bayesian posterior mean and 95% credible interval \<1500 grams by dose

Time frame: At birth

Low birth weight

Bayesian posterior mean and 95% credible interval \<2500 grams by dose

Time frame: birth

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

Time frame: birth

Gestational age

Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose

Time frame: birth

Data from ClinicalTrials.gov

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