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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: DHA Other: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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:

    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.


  2. 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).

  3. Cord Blood Phospholipids DHA [ Time Frame: Birth ]
    Newborn red blood cell phospholipids collected at birth.

  4. Cardiac Conduction Time [ Time Frame: Change from Baseline to 2 Months Post-natal ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

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


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 Medical Center
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
First Posted: November 3, 2009    Key Record Dates
Results First Posted: May 14, 2014
Last Update Posted: June 9, 2014
Last Verified: June 2014

Keywords provided by Kathleen Gustafson, Ph.D., University of Kansas:
DHA