Feasibility of Omega-3 Supplementation for Children With Language Impairments
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|ClinicalTrials.gov Identifier: NCT01640106|
Recruitment Status : Unknown
Verified July 2012 by McGill University Health Center.
Recruitment status was: Recruiting
First Posted : July 13, 2012
Last Update Posted : July 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Language Impairment||Dietary Supplement: Omega-3 Dietary Supplement: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||September 2013|
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|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640106
|Contact: Shuvo Ghosh, MD||514-412-4400 ext firstname.lastname@example.org|
|Contact: Jennifer Frei, BA||514-412-4400 ext email@example.com|
|McGill University/Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||Shuvo Ghosh, MD||MUHC Montreal Children's Hospital|