Phase 4
N=377
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Preterm Birth · Child Development
Bottom Line
View on ClinicalTrials.gov: NCT01576783 ↗Enrolled (actual)
377
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Erythrocyte Fatty Acid Levels — -2.1; 0.6; 2.0; -0.2 nmol/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) (Drug); Placebo (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sarah Keim
- Primary completion
- Apr 2017
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 |
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.
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). 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.