DHA Supplementation and Pregnancy Outcome

Susan Carlson, PhD

Status and phase: Completed; Phase 3

Conditions: Pregnancy

Treatments: Drug: DHA; Other: Placebo capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00266825

R01HD047315 (U.S. NIH Grant/Contract)

10186 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.

Full description

Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Enrollment: 350 patients

Sex: Female

Ages: 16 to 36 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant 8-20 wks at enrollment
• single fetus
• BMI <40

Exclusion criteria

• diabetes (Type I, ii, GDM)
• hypertension (primary, PIH, preeclampsia/eclampsia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

DHA capsules

Experimental group

Description:

DHA capsules

Treatment:

Drug: DHA

Placebo capsules

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Other: Placebo capsule