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Fatty Acid Dietary Supplement

DHA + AA Supplements for Premature Birth Development

N/A
Waitlist Available
Led By Sarah Keim, PhD
Research Sponsored by Sarah Keim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current age of 8 years, 180 days to 10 years, 180 days
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a single study visit when the child is between 8.5 years to 10.5 years
Awards & highlights

Study Summary

This trial is a follow-up to the Omega Tots trial to see if a daily fatty acid supplement taken during toddlerhood has any long-term effects on children born preterm.

Who is the study for?
This trial is for children aged between 8 years and 6 months to 10 years and 6 months who were born prematurely and took part in the original Omega Tots study. Children under the care of child services during their eligibility period cannot participate.Check my eligibility
What is being tested?
The study is examining the long-term effects of a daily dietary supplement containing fatty acids (DHA+AA) given during toddlerhood on the development of children born preterm, now that they are older.See study design
What are the potential side effects?
Since this is a follow-up study, it may not involve taking new interventions but monitoring for any long-term impacts from the original supplementation. Specific side effects from DHA+AA supplements can include mild digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 years, 6 months and 10 years, 6 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a single study visit when the child is between 8.5 years to 10.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and a single study visit when the child is between 8.5 years to 10.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
Executive Function (NIH Toolbox)
General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
Secondary outcome measures
Anthropometrics-Adiposity
Anthropometrics-Body Composition (height)
Anthropometrics-Body Composition (weight)
+11 more

Side effects data

From 2017 Phase 4 trial • 377 Patients • NCT01576783
37%
Gastrointestinal Symptoms
19%
Misc Symptoms
15%
ENT Symptoms
12%
Behavioral Symptoms
12%
Respiratory symptoms
6%
Skin/Limb Symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docosahexaenoic Acid + Arachidonic Acid
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Docosahexaenoic Acid + Arachidonic AcidExperimental Treatment1 Intervention
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Group II: PlaceboPlacebo Group1 Intervention
Corn oil supplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doconexent
FDA approved

Find a Location

Who is running the clinical trial?

Sarah KeimLead Sponsor
5 Previous Clinical Trials
653 Total Patients Enrolled
2 Trials studying Premature Birth
408 Patients Enrolled for Premature Birth
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,364 Total Patients Enrolled
65 Trials studying Premature Birth
119,133 Patients Enrolled for Premature Birth
Sarah Keim, PhDPrincipal InvestigatorNationwide Children's Hospital
4 Previous Clinical Trials
578 Total Patients Enrolled
2 Trials studying Premature Birth
408 Patients Enrolled for Premature Birth

Media Library

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) (Fatty Acid Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05191823 — N/A
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) (Fatty Acid Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05191823 — N/A
Premature Birth Research Study Groups: Docosahexaenoic Acid + Arachidonic Acid, Placebo
Premature Birth Clinical Trial 2023: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) Highlights & Side Effects. Trial Name: NCT05191823 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What previous research has been done on the combination of Docosahexaenoic Acid and Arachidonic Acid?

"At the moment, 4 clinical trials investigating Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) are in progress. One of these studies is currently at Phase 3 testing. These investigations have been set up in Baltimore and there are an additional 4 sites providing this therapy for research purposes."

Answered by AI

What are the qualifications necessary to partake in this research?

"This research requires 377 8-10 year olds with developmental issues to participate. In addition, the must have previously taken part in Omega Tots (NCT01576783) and their age range is from 8 years old and 180 days to 10 years old and 180 days."

Answered by AI

What is the upper limit to enrollment for this clinical experiment?

"The study is no longer accepting applicants as of January 10th, 2022. For those interested in alternative clinical trials, there are 319 studies currently recruiting individuals with developmental disabilities and four involving the combination of Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)."

Answered by AI

To what illnesses is the combination of Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) typically applied?

"Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) is a common medication for treating inadequate response to dietary changes, as well as hyperlipidemia, statin-resistant triglycerides, and nutritional deficiencies."

Answered by AI

What results are researchers expecting from this investigation?

"This study aims to measure Executive Function (NIH Toolbox) of children aged 8.5-10.5 years, with secondary objectives being the evaluation of Digit Span and Picture Span Subtests from Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V), Behavior Rating Inventory of Executive Function 2nd edition's Global Executive Composite Score (BRIEF-2), and Letter/Word Recognition, Math Computation, Object Naming Facility, and Associative Fluency subtests from Kaufman Test of Educational Achievement Third Edition (KTEA-3)."

Answered by AI

Are there any open slots available for volunteers in this experiment?

"Unfortunately, no more candidates are being accepted for this trial. The study was initially posted on December 1st 2021 and the most recent update came on January 10th 2022. If you wish to join another clinical trial, presently there is a total of 319 trials accepting participants with developmental disorders, 4 studies involving Docosahexaenoic Acid + Arachidonic Acid (DHA+AA), as well as child-focused research programmes recruiting volunteers."

Answered by AI

Does the research encompass participants over 35 years of age?

"This study requires participants that are between 8 and 10 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Omega Tots Long Term Follow-up
Sarah Keim 2021. "Omega Tots Long Term Follow-up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05191823.
~25 spots leftby Jun 2024
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