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 12, 2012
Last verified: June 2012
  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.


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 and heart rate variability [ Time Frame: 24 and 36 weeks gestation, 2 months postnatal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal red blood cell (RBC) phospholipids [ Time Frame: enrollment and delivery ] [ Designated as safety issue: Yes ]
  • Cord blood phospholipids DHA [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  • Neonatal Behavioral Assessment Scale (NBAS) scores [ Time Frame: within 2 weeks of delivery ] [ Designated as safety issue: Yes ]
  • Cardiac conduction time [ Time Frame: 24 and 36 weeks gestation, 2 months postnatal ] [ 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) from algal oil
Docosahexaenoic Acid (DHA) from algal oil
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

  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 to baseline or weight exceeds 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
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

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
DHA

ClinicalTrials.gov processed this record on April 15, 2014