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

Completed · Phase 4 · Has a placebo group

Conditions studied: Preterm Birth, Child Development

In brief

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.

Key facts

Study ID

NCT01576783

Run by

Sarah Keim

People needed

377

Starts

2012-04-26

Expected to finish

2017-04-06

Last updated by the study team

2021-06-29

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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