The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Cognitive, Visual and Immunological Development in Toddlers

Study ID
STU 032011-018

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Retina Foundation of the Southwest

Contact
Yolanda Castaneda
214-363-3911
ycastane@retinafoundation.org

Principal Investigator
Eileen Birch

Summary

Concise Summary of Project:
Study Design: We plan to conduct a parallel-design, randomized, double-blind, placebo-controlled clinical trial to assess cognition, executive function, vision, sleep, immunology, biochemical markers, growth and health in 114 children. Children will be randomized at 12-14 months of age to receive either:
* a micro-encapsulated LCP-supplement that can be sprinkled onto their normal foods from 12 to 36 months of age
* a micro-encapsulated placebo-supplement (containing corn oil) that can be sprinkled onto their normal foods from 12 to 36 months of age
* data will be collected through the age of 42 months

Two foil-packets containing either active intervention or placebo will provide 200mg DHa and 200mg aRa or 400 mg placebo oil per day to the toddler. Two packets of the powders will be added each day to prepared foods.

Participant Eligibility

Criteria for Inclusion of Subjects

* Toddlers (12 to 14 months of age at randomization)

* Full-term single birth

* Mother plans to discontinue formula feeding by 14 months of age

* Mother plans to wean toddler by 14 months; or plans to supplement with breast milk up to 2 times per day for up to 18 months

* English as the primary language in the home
Not all neurodevelopmental tests have a validated Spanish version available
Provision of bilingual educational psychologists for testing of select children is not feasible
Children who are bilingual or from English/Spanish-speaking households often have language delays during early childhood