Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01007110
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2009-11-02
Brief Title:
Effects of Docosahexaenoic Acid DHA on Fetal Cardiac Outcomes
Sponsor:
University of Kansas
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
The Effects of Docosahexaenoic Acid DHA on Fetal Cardiac Outcomes
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None