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Completed

NCT Number: NCT00266825

DHA Supplementation and Pregnancy Outcome

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.

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Key information

Conditions

Pregnancy

Age range

16 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DHA

Drug

600 mg DHA

Other names: docosahexaenoic acid

Placebo capsule

Other

Placebo capsule

Primary outcomes

  1. Percentage of Total Fatty Acids by Weight

    Time frame: at time of birth

    Measure of RBC-phospholipid-DHA at Birth

  2. Gestational Age

    Time frame: at time of birth

    Gestational age of babies at time of birth in days

  3. Birth Weight

    Time frame: at time of birth

    Weight of baby at birth

  4. Birth Length

    Time frame: at time of birth

    Length of baby at birth

Secondary outcomes

  1. Ponderal Index

    Time frame: at time of birth

    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.

  2. Gender of Babies

    Time frame: at time of birth

  3. Cord RBC-phospholipid-DHA

    Time frame: at time of birth

    Percentage of total fatty acids by weight in cord RBC

  4. Head Circumference

    Time frame: at time of birth

    Measure of circumference of baby's head in centimeters at time of birth.

  5. Preterm Births

    Time frame: births before week 37 of gestation

    Percentage of births occurring at less than 37 weeks of gestation.

Sponsors and collaborators

Lead sponsor

Susan Carlson, PhD

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Kansas University DHA Outcome Study (KUDOS)

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2005
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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