Prenatal DHA and Neurofunctional Development

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prenatal Docosahexaenoic Acid (DHA) & Neurofunctional Development

Conditions
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Use and Dose of Prenatal DHA Supplementation

Intervention / Treatment
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* Dietary Supplement: DHA 200mg
* Dietary Supplement: DHA 800mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DHA 200mg<br>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<br>* 4 50mg capsules of DHA to be taken by mouth daily<br>* Other names: Docosahexaenoic Acid;|
| Experimental: DHA 800mg<br>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<br>* 4 200mg capsules of DHA to be taken by mouth daily<br>* Other names: Docosahexaenoic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal-Infant DHA Equilibrium | 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) | 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) | 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 | 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 | 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 | 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 | Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 4 months. | 4 months postnatal age | 
| Infant Behavioral Assessment | Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 6 months. | 6 months postnatal age |