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

NCT01576783 | Completed Phase 4 Results

• 1 other identifier: 183210
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

Brief 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

Preterm Birth; Child Development

Outcome Measures

Primary Outcomes (4)

• Erythrocyte Fatty Acid Levels

  This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc

  Baseline to 180 days post-randomization

• Erythrocyte Fatty Acid Levels (Additional Data)

  This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc

  Baseline to 180 days post-randomization

• Enrollment and Trial Completion

  The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.

  Baseline to 180 days post-randomization

• Adherence

  The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc

  Baseline to 180 days post-randomization

Secondary Outcomes (2)

• (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)

  Baseline to 180 days post-randomization

• (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)

  Baseline to 180 days post-randomization

Other Outcomes (13)

• Brief Infant Sleep Questionnaire (BISQ)

  Baseline to 180 days post-randomization

• Body Composition

  Baseline to 180 days post-randomization

• Brief Infant Toddler Social Emotional Assessment (BITSEA)

  180 days post-randomization

Study Arms (2)

Docosahexaenoic Acid + Arachidonic Acid

EXPERIMENTAL

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Placebo

PLACEBO COMPARATOR

Corn oil supplement

Dietary Supplement: Placebo

Interventions

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) DRUG

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

Docosahexaenoic Acid + Arachidonic Acid

Placebo DIETARY_SUPPLEMENT

400 mg corn oil per day for 6 months

Placebo

Eligibility Criteria

• Age: 10 Months - 16 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 10-16 completed months (age corrected for prematurity) at baseline
• Discontinued regular breastfeeding and formula feeding at the time of randomization
• Gestational age \< 35 completed weeks at birth
• English is primary language in home
• Informed consent obtained and signed
• Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance

You may not qualify if:

• Feeding problems
• Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
• Weight \< 5th or \> 95th percentile for age, per WHO growth charts
• Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
• Plans to move out of the area within the next 6 months
• Known corn allergy
• Known soy allergy
• Known fish allergy

Sponsors & Collaborators

• Sarah Keim: lead
• Allen Foundation Inc.: collaborator
• March of Dimes: collaborator
• Cures Within Reach: collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (5)

• 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.

  PMID: 33768637 DERIVED

• 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.

  PMID: 31984781 DERIVED

• 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.

  PMID: 31538590 DERIVED

• 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.

  PMID: 30579584 DERIVED

• 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.

  PMID: 30357263 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Docosahexaenoic Acids; Arachidonic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Arachidonic Acids; Eicosanoids; Fatty Acids, Essential

Results Point of Contact

• Title: Dr. Sarah Keim
• Organization: Nationwide Children's Hospital

Sarah.Keim@nationwidechildrens.org

614-722-3177

Study Officials

• Sarah Keim, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: April 26, 2012
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: June 29, 2021
• Results First Posted: May 24, 2019

Record last verified: 2021-06

Locations

US (1)