NCT01007110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3 pregnancy

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 14, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

November 2, 2009

Results QC Date

February 27, 2014

Last Update Submit

June 2, 2014

Conditions

Pregnancy

Keywords

DHA

Outcome Measures

Primary Outcomes (1)

  • Heart Rate

    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 Outcomes (4)

  • Neonatal Behavioral Assessment Scale (NBAS) Scores

    within 2 weeks of delivery

  • Maternal Red Blood Cell (RBC) Phospholipids at Delivery

    Time of delivery, 36 weeks to term

  • Cord Blood Phospholipids DHA

    Birth

  • Cardiac Conduction Time

    Change from Baseline to 2 Months Post-natal

Study Arms (2)

Docosahexaenoic Acid (DHA)

ACTIVE COMPARATOR

Docosahexaenoic Acid (DHA)

Dietary Supplement: DHA

Placebo

PLACEBO COMPARATOR

soy/corn oil placebo

Other: Placebo

Interventions

DHADIETARY_SUPPLEMENT

Docosahexaenoic Acid (DHA) from algal oil

Also known as: Docosahexaenoic acid
Docosahexaenoic Acid (DHA)
PlaceboOTHER

Placebo capsule

Also known as: Algal oil
Placebo

Eligibility Criteria

Age16 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (3)

  • Gustafson KM, Carlson SE, Colombo J, Yeh HW, Shaddy DJ, Li S, Kerling EH. Effects of docosahexaenoic acid supplementation during pregnancy on fetal heart rate and variability: a randomized clinical trial. Prostaglandins Leukot Essent Fatty Acids. 2013 May;88(5):331-8. doi: 10.1016/j.plefa.2013.01.009. Epub 2013 Feb 20.

    PMID: 23433688BACKGROUND

  • Christifano DN, Taylor MK, Carlson SE, Colombo J, Gustafson KM. Higher maternal weight is related to poorer fetal autonomic function. J Dev Orig Health Dis. 2021 Jun;12(3):354-356. doi: 10.1017/S2040174420000653. Epub 2020 Jul 14.

    PMID: 32662379DERIVED

  • Hoyer D, Schmidt A, Gustafson KM, Lobmaier SM, Lakhno I, van Leeuwen P, Cysarz D, Preisl H, Schneider U. Heart rate variability categories of fluctuation amplitude and complexity: diagnostic markers of fetal development and its disturbances. Physiol Meas. 2019 Jul 3;40(6):064002. doi: 10.1088/1361-6579/ab205f.

    PMID: 31071684DERIVED

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Kathleen Gustafson, Ph.D.
Organization
University of Kansas Medical Center
kgustafson@kumc.edu
(913) 588-0065

Study Officials

  • Kathleen Gustafson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

June 9, 2014

Results First Posted

May 14, 2014

Record last verified: 2014-06

Locations

US(1)