Omega Tots Long Term Follow-up

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Sarah Keim
Study ID
NCT05191823
Status
Enrolling By Invitation

Conditions

  • Child Development
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
8 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) — DRUG
    200 mg DHA+ 200 mg AA per day for 6 months
  • Placebo — DIETARY_SUPPLEMENT
    400 mg corn oil per day for 6 months

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
May 2025
Primary completion
Jun 25, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
377 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Docosahexaenoic Acid + Arachidonic Acid
    Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
  • Placebo Comparator: Placebo
    Corn oil supplement

Primary Outcome Measure

General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II) [ Time Frame: A single study visit when the child is between 8.5 years to 10.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

Find similar trials in Columbus, OH

By research site
Nationwide Children's Hospital· Columbus, OH

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