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Prenatal DHA and Neurofunctional Development (PANDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709239
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Use and Dose of Prenatal DHA Supplementation Dietary Supplement: DHA 200mg Dietary Supplement: DHA 800mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Prenatal Docosahexaenoic Acid (DHA) & Neurofunctional Development
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 20, 2020
Actual Study Completion Date : August 16, 2021

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 Name: 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 Name: Docosahexaenoic Acid




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709239


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Kathleen Gustafson, PhD University of Kansas Medical Center
Publications of Results:
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02709239    
Other Study ID Numbers: STUDY00003792
1R01HD086001 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No