Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen Gustafson, Ph.D., University of Kansas
ClinicalTrials.gov Identifier:
NCT01007110
First received: November 2, 2009
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy
Dietary Supplement: DHA
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Heart Rate [ Time Frame: 24, 32 and 36 weeks gestational age ] [ Designated as safety issue: Yes ]
    Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.


Secondary Outcome Measures:
  • Neonatal Behavioral Assessment Scale (NBAS) Scores [ Time Frame: within 2 weeks of delivery ] [ Designated as safety issue: Yes ]

    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 Frame: Time of delivery, 36 weeks to term ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Newborn red blood cell phospholipids collected at birth.

  • Cardiac Conduction Time [ Time Frame: Change from Baseline to 2 Months Post-natal ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Placebo
Placebo capsule
Other Name: Algal oil

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.

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007110

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Kathleen Gustafson, PhD University of Kansas
  More Information

Publications:
Responsible Party: Kathleen Gustafson, Ph.D., Research Assistant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01007110     History of Changes
Other Study ID Numbers: 11625
Study First Received: November 2, 2009
Results First Received: February 27, 2014
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
DHA

ClinicalTrials.gov processed this record on September 29, 2014