Clinical Trial: Feasibility of Omega-3 Supplementation for Children With Language Impairments

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language

Brief Summary: The primary objective of this study is to obtain preliminary (pilot) data regarding the feasibility of using dietary omega-3 supplementation in children with significant delays in language skills; a related secondary objective is to compare adherence to a dosage schedule of two easy-to-take formulations. A tertiary objective of this study is to collect preliminary (pilot) data pre- and post-supplementation to identify potential improvement of skills in a specific area of language development.

Detailed Summary: HYPOTHESIS Hypothesis 1: Children with early developmental impairment in language will successfully take daily omega-3 fatty acid supplementation for a well-defined period of time (3 months); Hypothesis 2: Children with early developmental impairment will better adhere to administration of a small quantity of slightly fishy-tasting oil than to a large quantity of sweet-tasting paste; Hypothesis 3: A 3 month period of daily omega-3 supplementation will produce some improvement in fast-mapping language skills (a dynamic vocabulary learning skill that has been shown to rapidly improve after exposure to beneficial intervention).
Sponsor: McGill University Health Center

Current Primary Outcome: Change over 3 months in learning assessed by a fast-mapping task [ Time Frame: Assessed at time of diagnosis and 3 months after intervention ]

A simple "fast-mapping" task, which is a measure of language learning used widely in linguistics research, will be performed in the pre and post-intervention period. We will present a list of non-words selected with only early-developing sounds to ensure that they are within the repertoire of developmentally impaired children. Scores are calculated in terms of number of items successfully completed. An initial and final assessment of dynamic language learning will be done as an addendum to scores on standardized language tests that establish a language impairment diagnosis.


Original Primary Outcome: Same as current

Current Secondary Outcome: Feasibility of fish oil vs. chewable Concordix paste [ Time Frame: Given for 3 months as intervention ]

In order to estimate the relative success of administering paste vs. oil in relation to omega-3 vs. placebo, a repeated measures ANOVA will be used to test for significant differences. The primary measure will be parental report as "easy" vs. "difficult" to administer, and the analysis will be run as Between group (paste vs. oil) by Treatment arm (omega-3 vs. placebo) by Adminstration success (easy vs. difficult).


Original Secondary Outcome: Same as current

Information By: McGill University Health Center

Dates:
Date Received: June 26, 2012
Date Started: June 2012
Date Completion: September 2013
Last Updated: July 12, 2012
Last Verified: July 2012