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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD086001 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA 200mg | Active Comparator | Participants will receive 200mg DHA to take per day. Participants will be asked to take four capsules containing 50mg DHA each. |
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| DHA 800mg | Experimental | Participants will receive 800mg DHA to take per day. Participants will be asked to take four capsules containing 200mg DHA each. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA 200mg | Dietary Supplement | 4 50mg capsules of DHA to be taken by mouth daily |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Gustafson, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34552200 | Result | 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. | |
| 35715980 | Derived | 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. |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| DHA 800mg | Dietary Supplement | 4 200mg capsules of DHA to be taken by mouth daily |
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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 |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |