DHA Supplementation and Pregnancy Outcome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Kansas University DHA Outcome Study (KUDOS)

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: DHA
* Other: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant 8-20 wks at enrollment single fetus BMI <40 Exclusion Criteria: diabetes (Type I, ii, GDM) hypertension (primary, PIH, preeclampsia/eclampsia)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA capsules<br>DHA capsules | Drug: DHA<br>* 600 mg DHA<br>* Other names: docosahexaenoic acid;|
| Placebo Comparator: Placebo capsules<br>Placebo capsule | Other: Placebo capsule<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Total Fatty Acids by Weight | Measure of RBC-phospholipid-DHA at Birth | at time of birth | 
| Gestational Age | Gestational age of babies at time of birth in days | at time of birth | 
| Birth Weight | Weight of baby at birth | at time of birth | 
| Birth Length | Length of baby at birth | at time of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ponderal Index | Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics. | at time of birth | 
| Gender of Babies |  | at time of birth | 
| Cord RBC-phospholipid-DHA | Percentage of total fatty acids by weight in cord RBC | at time of birth | 
| Head Circumference | Measure of circumference of baby's head in centimeters at time of birth. | at time of birth | 
| Preterm Births | Percentage of births occurring at less than 37 weeks of gestation. | births before week 37 of gestation |