Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: DHA
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docosahexaenoic Acid (DHA)<br>Docosahexaenoic Acid (DHA) | Dietary Supplement: DHA<br>* Docosahexaenoic Acid (DHA) from algal oil<br>* Other names: Docosahexaenoic acid;|
| Placebo Comparator: Placebo<br>soy/corn oil placebo | Other: Placebo<br>* Placebo capsule<br>* Other names: Algal oil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age. | 24, 32 and 36 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Behavioral Assessment Scale (NBAS) Scores | 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. | within 2 weeks of delivery | 
| Maternal Red Blood Cell (RBC) Phospholipids at Delivery | 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). | Time of delivery, 36 weeks to term | 
| Cord Blood Phospholipids DHA | Newborn red blood cell phospholipids collected at birth. | Birth | 
| Cardiac Conduction Time |  | Change from Baseline to 2 Months Post-natal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DHA