NCT05191823

Omega Tots Long Term Follow-up

Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (estimated)
• Sponsor: Sarah Keim · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Preterm Birth
• Child Development

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-06-25
• Completion: 2026-06-30
• First posted: 2022-01-14
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States