Prenatal DHA and Neurofunctional Development (PANDA)

October 11, 2021 updated by: University of Kansas Medical Center

Prenatal Docosahexaenoic Acid (DHA) & 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DHA 200mg
Participants will receive 200mg DHA to take per day. Participants will be asked to take four capsules containing 50mg DHA each.
Dietary supplement: DHA 200mg
4 50mg capsules of DHA to be taken by mouth daily
Other Names:
  • Docosahexaenoic Acid
Experimental: DHA 800mg
Participants will receive 800mg DHA to take per day. Participants will be asked to take four capsules containing 200mg DHA each.
Dietary supplement: DHA 800mg
4 200mg capsules of DHA to be taken by mouth daily
Other Names:
  • Docosahexaenoic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Delivery (birth)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
32 weeks gestational age
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.
36 weeks gestational age
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.
1 month postnatal age
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.
6 months postnatal age
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.
12 months postnatal age
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.
4 months postnatal age
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.
6 months postnatal age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Kathleen Gustafson, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 20, 2020

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00003792
  • 1R01HD086001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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