N/A N=64 Randomized Triple-blind Basic Science

Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress

Healthy Pregnant Women

Bottom Line

View on ClinicalTrials.gov: NCT01158976 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Maternal Cortisol Levels — 0.28; 0.34 ug/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Docosahexanoic Acid (Dietary_supplement); Placebo (Other)
Age: Adult · 20+ yrs
Sex: Female
Sponsor: University of Chicago
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Maternal Cortisol Levels	0.22; 0.23	—
PRIMARY Maternal Cortisol Levels	0.22; 0.23	—
PRIMARY Maternal Cortisol Levels	0.22; 0.23	—
PRIMARY Infant Cortisol Levels	0.21; 0.31	—
PRIMARY Infant Cortisol Levels	0.21; 0.31	—
PRIMARY Infant Cortisol Levels	0.21; 0.31	—
SECONDARY Maternal Depression Symptoms	12.12; 11.35	—
SECONDARY Maternal Depression Symptoms	12.12; 11.35	—
SECONDARY Maternal Depression Symptoms	12.12; 11.35	—
SECONDARY Maternal Perceived Stress Scale (PSS) Score	27.77; 29	—
SECONDARY Maternal Perceived Stress Scale Score	27.47; 29.29	—
SECONDARY Maternal Perceived Stress Scale Score	27.47; 29.29	—
SECONDARY Infant Birth Weight	3074.39; 2919.56	—
SECONDARY Percentage of Infants Who Had a 1-minute Apgar Scores of 9	75.8; 59.1	—
SECONDARY Gestational Age (GA)	38.85; 38.84	—
SECONDARY Infant's Receptive Communication Scaled Score	4.88; 4.33	—
SECONDARY Infant's Expressive Communication Scaled Score	6.21; 6.00	—
SECONDARY Infant's Fine Motor Skills Scaled Score	2.38; 2.33	—
SECONDARY Infant's Gross Motor Skills Scaled Score	1.65; 1.60	—

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.

Eligibility Criteria

Inclusion Criteria

African American race
age between 20 and 34 years
16-21 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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01158976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.