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Completed

NCT Number: NCT02709239

Prenatal DHA and Neurofunctional Development

The purpose of this study is to learn how much DHA to give to mothers in order to provide enough to the baby. Researchers will also learn if there are differences in development of the baby up to 12 months after birth.

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Key information

Conditions

Use and Dose of Prenatal DHA Supplementation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

Docosahexaenoic acid (DHA) is an essential nutrient. Our bodies make DHA from the foods we eat. If we eat foods with a lot of DHA, like fatty ocean fish, we have more DHA in our bodies. DHA is found in all cells of the body but is especially high in nerve cells of the brain and eye. Babies get DHA from the mother when they're in the womb. After birth, they can get DHA from breast milk or infant formulas.

This study will enroll pregnant women and follow them and their baby until the baby is 12 months old. Changes in the development of the baby will be tracked. Half of the participants in this study will receive 200mg of DHA to take daily. The other half of participants will receive 800mg of DHA to take daily. Participants, along with the researchers, will not know which dose of DHA they are receiving.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women in their 12th to 20th week of gestation
  • Participants agree to consume the study capsules from enrollment to delivery
  • Healthy weight, overweight and obese women (determined by body mass index; BMI) are eligible
  • Must be available by telephone

Exclusion criteria

  • Underweight women and women who exceed 250 lbs at enrollment
  • Women with serious systemic infection, cancer, major organ disease or systemic lupus erythematosus
  • Women with multiple infants or fetal diagnosis of congenital cardiac structural or conduction defects or brain malformations
  • Diagnosis of Type I diabetes, and/or hypertension
  • Reported drug and/or alcohol abuse
  • Unwilling to take capsules, or be contacted by phone
  • Do not understand English

Treatment and study plan

DHA 200mg

Dietary Supplement

4 50mg capsules of DHA to be taken by mouth daily

Other names: Docosahexaenoic Acid

DHA 800mg

Dietary Supplement

4 200mg capsules of DHA to be taken by mouth daily

Other names: Docosahexaenoic Acid

Primary outcomes

  1. Maternal-Infant DHA Equilibrium

    Time frame: Delivery (birth)

    Maternal blood samples and infant cord blood will be collected at delivery and Red Blood Cell (RBC) DHA concentrations between maternal-infant pairs will be compared. Maternal-Infant DHA Equilibrium occurs if newborn cord blood DHA is less than or equal to the mother's DHA at delivery.

Secondary outcomes

  1. Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS)

    Time frame: 32 weeks gestational age

    Group comparisons will be made between time-domain metrics of fetal HRV (SDNN, RMSSD) and fABAS at two time points.

  2. Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS)

    Time frame: 36 weeks gestational age

    Group comparisons will be made between time-domain metrics of fetal HRV (SDNN, RMSSD) and fABAS at two time points.

  3. Infant Neurodevelopment

    Time frame: 1 month postnatal age

    Brain neurophysiology will be measured at 1 month of age. Assessments of band-limited spectral power during resting-state will be assessed. Event-related potentials (ERP) to auditory stimuli will be recorded. Group comparisons will be made between measures of resting state spectral power and auditory ERP components.

  4. Infant Neurodevelopment

    Time frame: 6 months postnatal age

    Brain neurophysiology will be measured at 6 months of age. Assessments of band-limited spectral power during resting-state will be assessed. Event-related potentials (ERP) to visual stimuli will be recorded. Group comparisons will be made between measures of resting state spectral power and visual ERP components.

  5. Infant Neurodevelopment

    Time frame: 12 months postnatal age

    Brain neurophysiology will be measured at 12 months of age. Assessments of band-limited spectral power during resting-state will be assessed. Event-related potentials (ERP) to visual stimuli will be recorded. Group comparisons will be made between measures of resting state spectral power and visual ERP components.

  6. Infant Behavioral Assessment

    Time frame: 4 months postnatal age

    Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 4 months.

  7. Infant Behavioral Assessment

    Time frame: 6 months postnatal age

    Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 6 months.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Official study title

Prenatal Docosahexaenoic Acid (DHA) & Neurofunctional Development

Acronym: PANDA

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Mar 16, 2016
Registry last updated
Oct 19, 2021

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.