NCT02647723

Brief Summary

The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
8mo left

Started Jan 2016

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

July 25, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

11 years

First QC Date

January 4, 2016

Results QC Date

May 15, 2024

Last Update Submit

April 15, 2025

Conditions

PregnancyChild Development

Keywords

Omega-3Fatty aciddocosahexaenoicPregnantneurodevelopmentstressurbanafrican-americansupplementnutritionmental health

Outcome Measures

Primary Outcomes (2)

  • Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4

    Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress

    16 months

  • Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3

    Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress

    12 months

Study Arms (2)

Oral supplement for pregnant women

EXPERIMENTAL

450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy

Dietary Supplement: DHA

Sugar pill

PLACEBO COMPARATOR

450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy

Dietary Supplement: Sugar pill

Interventions

DHADIETARY_SUPPLEMENT

2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks

Also known as: Omega-3, docosahexaenoic acid
Oral supplement for pregnant women
Sugar pillDIETARY_SUPPLEMENT

2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks

Also known as: soybean oil
Sugar pill

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 34
  • Household recipient 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:

  • Reports of known medial complications
  • Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report)
  • Use of blood thinners or anti-coagulants
  • Use of psychotropic medications
  • Allergy to iodine and/or soy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Docosahexaenoic AcidsSugarsSoybean Oil

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsCarbohydratesFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

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

Study Officials

  • Kathryn Keenan, Ph.D

    University of Chicago

    PRINCIPAL INVESTIGATOR

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, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 22, 2025

Results First Posted

July 25, 2024

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)