Prenatal DHA and Neurofunctional Development
- Conditions
- Use and Dose of Prenatal DHA Supplementation
- Interventions
- Dietary Supplement: DHA 200mgDietary Supplement: DHA 800mg
- Registration Number
- NCT02709239
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DHA 200mg DHA 200mg Participants will receive 200mg DHA to take per day. Participants will be asked to take four capsules containing 50mg DHA each. DHA 800mg DHA 800mg Participants will receive 800mg DHA to take per day. Participants will be asked to take four capsules containing 200mg DHA each.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Infant Behavioral Assessment 6 months postnatal age Heart-rate derived attention metrics and ocular latency (eye movements) will be recorded at 6 months.
Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS) 36 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 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.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States