CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 377 enrolled
Drug / intervention
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) +1 moredrug
Likely dose
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576783
NCT01576783Phase 4Completed
CompareCT.gov

Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

Sarah Keim·interventional·Posted Apr 12, 2012·Updated Jun 29, 2021

In Brief

A Phase 4 clinical trial evaluating Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) and Placebo for Preterm Birth and Child Development. Completed, enrolled 377 participants across 1 site.

Detailed Summary

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth, Child Development
CountriesUnited States
CollaboratorsAllen Foundation Inc., March of Dimes, Cures Within Reach, Health Resources and Services Administration (HRSA)

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2012
Enrollment StartApr 26, 2012
Primary CompletionApr 6, 2017
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.2 years ago

Interventions

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)drug

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

Placebodietary

400 mg corn oil per day for 6 months