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Omega-3 Fatty Acid Supplement

DHA Supplementation for Pregnancy and Child Development (NAPS Trial)

N/A
Waitlist Available
Led By Kathryn Keenan, Ph.D
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 34
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months

Summary

This trial aims to see if taking extra nutrients during pregnancy can help improve the health of the mother and the baby. It will also investigate if the benefits of these supplements on the baby's development are related

Who is the study for?
This trial is for pregnant women aged 18-34 who are on public assistance due to low income and consume less than two fish servings per week, indicating low levels of DHA.
What is being tested?
The study is testing if taking DHA supplements during pregnancy can improve mothers' health, infant birth weight, and brain development. It also looks at whether these benefits are linked to reduced stress in the mother.
What are the potential side effects?
DHA is generally considered safe with few side effects; however, some may experience mild digestive discomfort or a fishy aftertaste. The sugar pill (placebo) should not cause any side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 34 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral supplement for pregnant womenExperimental Treatment1 Intervention
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
Group II: Sugar pillPlacebo Group1 Intervention
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DHA
2009
Completed Phase 3
~3660

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER
1,783 Previous Clinical Trials
16,357,023 Total Patients Enrolled
University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
758,906 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,049 Previous Clinical Trials
2,730,977 Total Patients Enrolled
~2 spots leftby Dec 2024
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