Use and Dose of Prenatal DHA Supplementation
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTDHA 200mg
4 50mg capsules of DHA to be taken by mouth daily
DIETARY_SUPPLEMENTDHA 800mg
4 200mg capsules of DHA to be taken by mouth daily
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal-Infant DHA Equilibrium | 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
| Measure | Time frame | Description |
|---|---|---|
| Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS) | 32 weeks gestational age | Group comparisons will be made between time-domain metrics of fetal HRV (SDNN, RMSSD) and fABAS at two time points. |
| Infant Neurodevelopment | 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. |
| Infant Behavioral Assessment | 4 months postnatal age | Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 4 months. |
Countries
United States
Outcome results
None listed