Assessment of DHA On Reducing Early Preterm Birth

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

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.

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