Feasibility of Omega-3 Supplementation for Children With Language Impairments
Recruitment status was Recruiting
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.
Dietary Supplement: Omega-3
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language|
- Change over 3 months in learning assessed by a fast-mapping task [ Time Frame: Assessed at time of diagnosis and 3 months after intervention ] [ Designated as safety issue: No ]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.
- Feasibility of fish oil vs. chewable Concordix paste [ Time Frame: Given for 3 months as intervention ] [ Designated as safety issue: No ]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).
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Treatment arm, using the omega-3 product (fish oil/paste)
Dietary Supplement: Omega-3
800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
Other Name: Concordix chewable paste
|Placebo Comparator: Control||Dietary Supplement: Placebo|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640106
|Contact: Shuvo Ghosh, MD||514-412-4400 ext email@example.com|
|Contact: Jennifer Frei, BA||514-412-4400 ext firstname.lastname@example.org|
|McGill University/Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||Shuvo Ghosh, MD||MUHC Montreal Children's Hospital|