Clinical trial NCT02709239: Prenatal DHA and Neurofunctional Development
Official title: Prenatal Docosahexaenoic Acid (DHA) & Neurofunctional Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use and Dose of Prenatal DHA Supplementation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-03-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Maternal-Infant DHA Equilibrium
timeFrame: Delivery (birth)
Secondary outcomes:
measure: Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS)
timeFrame: 32 weeks gestational age
measure: Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS)
timeFrame: 36 weeks gestational age
measure: Infant Neurodevelopment
timeFrame: 1 month postnatal age
measure: Infant Neurodevelopment
timeFrame: 6 months postnatal age
measure: Infant Neurodevelopment
timeFrame: 12 months postnatal age
measure: Infant Behavioral Assessment
timeFrame: 4 months postnatal age
measure: Infant Behavioral Assessment
timeFrame: 6 months postnatal age
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kathleen Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustafson KM, Christifano DN, Hoyer D, Schmidt A, Carlson SE, Colombo J, Mathis NB, Sands SA, Chollet-Hinton L, Brown AR, Mudaranthakam DP, Gajewski BJ. Prenatal docosahexaenoic acid effect on maternal-infant DHA-equilibrium and fetal neurodevelopment: a randomized clinical trial. Pediatr Res. 2022 Jul;92(1):255-264. doi: 10.1038/s41390-021-01742-w. Epub 2021 Sep 22.
citation: Christifano DN, Chollet-Hinton L, Hoyer D, Schmidt A, Gustafson KM. Intake of eggs, choline, lutein, zeaxanthin, and DHA during pregnancy and their relationship to fetal neurodevelopment. Nutr Neurosci. 2023 Aug;26(8):749-755. doi: 10.1080/1028415X.2022.2088944. Epub 2022 Jun 17.