Phase 4
Completed N=377
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Source: ClinicalTrials.gov NCT01576783 ↗Enrolled (actual)
377
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Erythrocyte Fatty Acid Levels — -2.1; 0.6; 2.0; -0.2 nmol/mL — p=<0.001
◆ Published Evidence
Established
45citations · ~6 / year
Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial.
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.
Linked Publications (5)
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Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial.
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Gaps and Factors Related to Receipt of Care within a Medical Home for Toddlers Born Preterm.
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Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial.
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To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.
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Docosahexaenoic and arachidonic acid supplementation at 1 year has mixed effects on development and behaviour at age 2 for preterm children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erythrocyte Fatty Acid Levels |
-2.1; 0.6; 2.0; -0.2; 0.2; 0.4 | <0.001 sig |
| PRIMARY Erythrocyte Fatty Acid Levels (Additional Data) |
-3.2; 1.6 | <0.001 sig |
| PRIMARY Enrollment and Trial Completion |
172; 163; 166; 168 | — |
| PRIMARY Adherence |
80.6; 80.7 | — |
| SECONDARY (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form) |
-0.7; -0.5; 0.6; 0.5 | .13 |
| SECONDARY (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III) |
-2.6; -3.7; -0.5; 0.2; -0.6; -0.4 | .66 |
Eligibility Criteria
Inclusion Criteria
- Age 10-16 completed months (age corrected for prematurity) at baseline
- Discontinued regular breastfeeding and formula feeding at the time of randomization
- Gestational age 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
Data sourced from ClinicalTrials.gov (NCT01576783) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.