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Completed

NCT Number: NCT01007110

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.

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Key information

Conditions

Pregnancy

Age range

16 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA

Dietary Supplement

Docosahexaenoic Acid (DHA) from algal oil

Other names: Docosahexaenoic acid

Placebo

Other

Placebo capsule

Other names: Algal oil

Primary outcomes

  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 outcomes

  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:

    • 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.

  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

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2009
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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