Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Phase 3

Completed

Conditions: Pregnancy

Interventions: Dietary Supplement: DHA
Other: Placebo

Registration Number: NCT01007110

Lead Sponsor: University of Kansas

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 67

Inclusion Criteria

Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
Agree to consume study capsules from enrollment until delivery
BMI <40 at baseline or weight does not exceed 300 pounds
No serious illnesses likely to confound study outcomes
Available by phone

Exclusion Criteria

Less than 16 or greater than 35.99 years of age at enrollment
BMI >40 at baseline
Any serious illness likely to confound primary study outcomes
Expecting multiple infants
Diabetes (Type I, II or gestational) at baseline
Elevated blood pressure due to any cause (systolic BP >= 140 mm Hg
Gestational age at baseline < 12 weeks or > 20 weeks
Unable to provide informed consent in English

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docosahexaenoic Acid (DHA)	DHA	Docosahexaenoic Acid (DHA)
Placebo	Placebo	soy/corn oil placebo

Primary Outcome Measures

Name	Time	Method
Heart Rate	24, 32 and 36 weeks gestational age	Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.

Secondary Outcome Measures

Name	Time	Method
Neonatal Behavioral Assessment Scale (NBAS) Scores	within 2 weeks of delivery	The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas. For behavioral items a higher score corresponds to more desirable outcomes: 1. Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27. 2. Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 - 63. 3. 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. 4. 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. 5. Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36. 6. 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 of delivery, 36 weeks to term	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	Birth	Newborn red blood cell phospholipids collected at birth.
Cardiac Conduction Time	Change from Baseline to 2 Months Post-natal