Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
|ClinicalTrials.gov Identifier: NCT01007110|
Recruitment Status : Completed
First Posted : November 3, 2009
Results First Posted : May 14, 2014
Last Update Posted : June 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: DHA Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes|
|Study Start Date :||May 2009|
|Primary Completion Date :||May 2011|
|Study Completion Date :||July 2011|
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
- Heart Rate [ Time Frame: 24, 32 and 36 weeks gestational age ]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 ]
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 ]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 ]Newborn red blood cell phospholipids collected at birth.
- Cardiac Conduction Time [ Time Frame: Change from Baseline to 2 Months Post-natal ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007110
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Kathleen Gustafson, PhD||University of Kansas Medical Center|