Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007110
• Other study ID #: 11625
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2009
• Last updated: June 2, 2014
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• DHA
Docosahexaenoic Acid (DHA) from algal oil

Other:
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gustafson KM, Carlson SE, Colombo J, Yeh HW, Shaddy DJ, Li S, Kerling EH. Effects of docosahexaenoic acid supplementation during pregnancy on fetal heart rate and variability: a randomized clinical trial. Prostaglandins Leukot Essent Fatty Acids. 2013 May;88(5):331-8. doi: 10.1016/j.plefa.2013.01.009. Epub 2013 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Cord Blood Phospholipids DHA	Newborn red blood cell phospholipids collected at birth.	Birth	Yes
Secondary	Cardiac Conduction Time		Change from Baseline to 2 Months Post-natal	Yes