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

Sarah Keim

Status and phase: Completed; Phase 4

Conditions: Child Development; Preterm Birth

Treatments: Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01576783

183210

Details and patient eligibility

About

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

Enrollment: 377 patients

Sex: All

Ages: 10 to 16 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 10-16 completed months (age corrected for prematurity) at baseline
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

1. Feeding problems
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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377 participants in 2 patient groups, including a placebo group

Docosahexaenoic Acid + Arachidonic Acid

Experimental group

Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Treatment:

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

Placebo

Placebo Comparator group

Description:

Corn oil supplement

Treatment:

Dietary Supplement: Placebo