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

NCT01576783 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2021-06-29

Study results available
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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.

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

  • Allen Foundation Inc.

    collaborator OTHER

  • March of Dimes

    collaborator OTHER

  • Cures Within Reach

    collaborator OTHER

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • Sarah Keim

    lead OTHER

Principal Investigators

  • Sarah Keim, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
16 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-26
Primary Completion
2017-04-06
Completion
2017-04-06

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 NCT01576783 on ClinicalTrials.gov