Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

June 2, 2014 updated by: Kathleen Gustafson, Ph.D., University of Kansas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docosahexaenoic Acid (DHA)
Dietary supplement: DHA
Docosahexaenoic Acid (DHA) from algal oil
Other Names:
  • Docosahexaenoic acid
Placebo Comparator: Placebo
soy/corn oil placebo
Other: Placebo
Placebo capsule
Other Names:
  • Algal oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24, 32 and 36 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2 weeks of delivery
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).
Time of delivery, 36 weeks to term
Cord Blood Phospholipids DHA
Time Frame: Birth
Newborn red blood cell phospholipids collected at birth.
Birth
Cardiac Conduction Time
Time Frame: Change from Baseline to 2 Months Post-natal
Change from Baseline to 2 Months Post-natal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Investigators

  • Principal Investigator: Kathleen Gustafson, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11625 (Stanford University Med. Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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