deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01576783

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

Sponsor: Allen Foundation Inc.

Conditions Child Development Preterm Birth
Interventions Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) Placebo
Updated 13 times since 2017 Last updated: Jun 9, 2021 Started: Apr 26, 2012 Primary completion: Apr 6, 2017 Completion: Apr 6, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Child Development and Preterm Birth, this trial is completed. The trial is conducted by Allen Foundation Inc. and has accumulated 13 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Nov 2018 · 3 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~May 2020 · 11 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Mar 2021 — Sep 2021 [monthly]

    Completed PHASE4

  5. Jan 2021 — Mar 2021 [monthly]

    Completed PHASE4

▶ Show 8 earlier versions

  1. May 2020 — Jan 2021 [monthly]

    Completed PHASE4

  2. Jun 2019 — May 2020 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  3. Nov 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE4

  4. Aug 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE4

  5. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE4

  6. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE4

    Status: Enrolling By Invitation → Active Not Recruiting

  7. Feb 2017 — Aug 2017 [monthly]

    Enrolling By Invitation PHASE4

  8. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation PHASE4

    First recorded

Apr 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Allen Foundation Inc.
  • Cures Within Reach
  • Health Resources and Services Administration (HRSA)
  • March of Dimes
  • Sarah Keim
Data source: Nationwide Children's Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations