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 ]
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 ]
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