NCT02626299

Assessment of DHA On Reducing Early Preterm Birth

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
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)
DRUG	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.

Timeline

• Start date: 2016-06-08
• Primary completion: 2020-10-05
• Completion: 2020-10-05
• First posted: 2015-12-10
• Last updated: 2021-03-30

Locations

3 sites across 1 country: United States