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Omega Tots Long Term Follow-up

NCT05191823 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2025-05-11

No results posted yet for this study

Summary

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

Conditions

Interventions

DRUG

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

200 mg DHA+ 200 mg AA per day for 6 months

DIETARY_SUPPLEMENT

Placebo

400 mg corn oil per day for 6 months

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Sarah Keim

    lead OTHER

Principal Investigators

  • Sarah Keim, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-06-25
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05191823 on ClinicalTrials.gov