Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes|
- Heart Rate [ Time Frame: 24, 32 and 36 weeks gestational age ] [ Designated as safety issue: Yes ]Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.
- Neonatal Behavioral Assessment Scale (NBAS) Scores [ Time Frame: within 2 weeks of delivery ] [ Designated as safety issue: Yes ]
The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.
For behavioral items a higher score corresponds to more desirable outcomes:
- Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.
- Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 - 63.
- Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.
- Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.
- Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.
- Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.
Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite.
- Maternal Red Blood Cell (RBC) Phospholipids at Delivery [ Time Frame: Time of delivery, 36 weeks to term ] [ Designated as safety issue: Yes ]Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).
- Cord Blood Phospholipids DHA [ Time Frame: Birth ] [ Designated as safety issue: Yes ]Newborn red blood cell phospholipids collected at birth.
- Cardiac Conduction Time [ Time Frame: Change from Baseline to 2 Months Post-natal ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Docosahexaenoic Acid (DHA)
Docosahexaenoic Acid (DHA)
Dietary Supplement: DHA
Docosahexaenoic Acid (DHA) from algal oil
Other Name: Docosahexaenoic acid
Placebo Comparator: Placebo
soy/corn oil placebo
Other Name: Algal oil
We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007110
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Kathleen Gustafson, PhD||University of Kansas|