Assessment of DHA On Reducing Early Preterm Birth (ADORE)

University of Kansas

Status and phase: Completed; Phase 3

Conditions: Preterm Birth

Treatments: Drug: Docosahexaenoic acid - 800mg/day; Drug: Docosahexaenoic acid - 200mg/day; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02626299

STUDY00003455

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,100 participants in 2 patient groups, including a placebo group

200 mg/day DHA

Placebo Comparator group

Description:

Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.

Treatment:

Other: Placebo

Drug: Docosahexaenoic acid - 200mg/day

1000 mg/day DHA

Experimental group

Description:

The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.

Treatment:

Drug: Docosahexaenoic acid - 200mg/day

Drug: Docosahexaenoic acid - 800mg/day