Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
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|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|
|Actual Primary Completion Date :||May 2011|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|