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Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
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.
The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).
Age
8 - 10 years
Sex
ALL
Healthy Volunteers
No
Nationwide Children's Hospital
Columbus, Ohio, United States
Start Date
December 1, 2021
Primary Completion Date
June 25, 2024
Completion Date
June 30, 2026
Last Updated
May 11, 2025
377
ESTIMATED participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
DRUG
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Sarah Keim
Collaborators
Data Source & Attribution
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