NCT01158976

Brief Summary

This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more modulated hormonal response to stress, and more optimal regulation of emotion and attention in the infant, even within the context inner-city poverty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
5 years until next milestone

Results Posted

Study results publicly available

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

April 1, 2018

Enrollment Period

3.5 years

First QC Date

June 28, 2010

Results QC Date

May 2, 2017

Last Update Submit

April 30, 2018

Conditions

Healthy Pregnant Women

Outcome Measures

Primary Outcomes (6)

  • Maternal Cortisol Levels

    Maternal stress regulation at 30 weeks gestation

    Baseline (pre-stressor)

  • Maternal Cortisol Levels

    Maternal stress regulation at 30 weeks gestation

    20 minutes post-stressor

  • Maternal Cortisol Levels

    Maternal stress regulation at 30 weeks gestation

    45 minutes post stressor

  • Infant Cortisol Levels

    Infant cortisol response to the Still-Face paradigm before stressor

    4 months post-partum

  • Infant Cortisol Levels

    Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor

    4 months post-partum

  • Infant Cortisol Levels

    Infant cortisol response to the Still-Face paradigm 45 mins post-stressor

    4 months post-partum

Secondary Outcomes (13)

  • Maternal Depression Symptoms

    16-21 weeks gestation

  • Maternal Depression Symptoms

    24 weeks

  • Maternal Depression Symptoms

    30 weeks gestation

  • Maternal Perceived Stress Scale (PSS) Score

    Baseline: 16 - 21 weeks

  • Maternal Perceived Stress Scale Score

    24 weeks gestation

  • +8 more secondary outcomes

Study Arms (2)

DHA supplementation

EXPERIMENTAL
Dietary Supplement: Docosahexanoic Acid

Soybean Oil

PLACEBO COMPARATOR
Other: Placebo

Interventions

Docosahexanoic AcidDIETARY_SUPPLEMENT

450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery

Also known as: Nordic Naturals ProDHA
DHA supplementation
PlaceboOTHER

soybean oils with strawberry flavoring

Soybean Oil

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African American race
  • age between 20 and 34 years
  • weeks gestation
  • household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
  • low levels of DHA consumption as defined as less than two fish servings per week.

You may not qualify if:

  • known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
  • alcohol use
  • cigarettes or use of illegal substances (by maternal report)
  • use of blood thinners or anti-coagulants
  • use of psychotropic medications
  • Body Mass Index \>40
  • allergy to iodine and/or soy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Keenan K, Hipwell AE, Bortner J, Hoffmann A, McAloon R. Association between fatty acid supplementation and prenatal stress in African Americans: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1080-1087. doi: 10.1097/AOG.0000000000000559.

    PMID: 25415158DERIVED

Limitations and Caveats

Small sample size and attrition of participants over time likely affect the reliability of the findings. There may have been some differential selection bias across the two groups. We relied on maternal report of uptake.

Results Point of Contact

Title
Kathry Keenan
Organization
University of Chicago
kekeenan@uchicago.edu
773-702-4449

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2010

First Posted

July 8, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 30, 2018

Results First Posted

May 30, 2018

Record last verified: 2018-04

Locations

US(2)