NCT01007110

Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DHA	Docosahexaenoic Acid (DHA) from algal oil
OTHER	Placebo	Placebo capsule

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-05-01
• Completion: 2011-07-01
• First posted: 2009-11-03
• Last updated: 2014-06-09
• Results posted: 2014-05-14

Locations

1 site across 1 country: United States