Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
NCT ID: NCT01576783
Last Updated: 2021-06-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
377 participants
INTERVENTIONAL
2012-04-26
2017-04-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Omega Tots Long Term Follow-up
NCT05191823
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
NCT00226187
Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
NCT01248728
Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.
NCT02339727
Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
NCT02346773
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months
Placebo
Corn oil supplement
Placebo
400 mg corn oil per day for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months
Placebo
400 mg corn oil per day for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Discontinued regular breastfeeding and formula feeding at the time of randomization
3. Gestational age \< 35 completed weeks at birth
4. English is primary language in home
5. Informed consent obtained and signed
6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance
Exclusion Criteria
2. Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
3. Weight \< 5th or \> 95th percentile for age, per WHO growth charts
4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
5. Plans to move out of the area within the next 6 months
6. Known corn allergy
7. Known soy allergy
8. Known fish allergy
10 Months
16 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allen Foundation Inc.
OTHER
March of Dimes
OTHER
Cures Within Reach
OTHER
Health Resources and Services Administration (HRSA)
FED
Sarah Keim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Keim
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Keim, PhD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Boone KM, Pattison K, Pelak G, Sheppard KW, Rausch J, Yeates KO, Nelin MA, Klebanoff MA, Turner AN, Rogers LK, Keim SA. Docosahexaenoic and arachidonic acid supplementation at 1 year has mixed effects on development and behaviour at age 2 for preterm children. Acta Paediatr. 2021 Jul;110(7):2082-2083. doi: 10.1111/apa.15858. Epub 2021 Apr 12. No abstract available.
Sullivan JA, Wiese AM, Boone KM, Rausch J, Keim SA. To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial. Clin Trials. 2020 Apr;17(2):223-230. doi: 10.1177/1740774519893307. Epub 2020 Jan 27.
Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial. J Clin Sleep Med. 2019 Sep 15;15(9):1197-1208. doi: 10.5664/jcsm.7902.
Boone KM, Nelin MA, Chisolm DJ, Keim SA. Gaps and Factors Related to Receipt of Care within a Medical Home for Toddlers Born Preterm. J Pediatr. 2019 Apr;207:161-168.e1. doi: 10.1016/j.jpeds.2018.10.065. Epub 2018 Dec 19.
Keim SA, Boone KM, Klebanoff MA, Turner AN, Rausch J, Nelin MA, Rogers LK, Yeates KO, Nelin L, Sheppard KW. Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial. JAMA Pediatr. 2018 Dec 1;172(12):1126-1134. doi: 10.1001/jamapediatrics.2018.3082.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
183210
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.