Feasibility of Omega-3 Supplementation for Children With Language Impairments

Language Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01640106
• Other study ID #: 09-164-PED
• Status: Terminated
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2019
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 42 Months

Eligibility

Inclusion Criteria:

• children in the chronological age range of 24 to 42 months at the time of initial assessment

• diagnosis of expressive, receptive or mixed language impairment (LI) by a certified Speech-Language Pathologist (S-LP)

• ability to take daily omega-3 supplementation (with caregiver assistance)

Exclusion Criteria:

• children with any organic disease processes or genetic syndromes, or known developmental disorders such as autism that may present with language impairment

• children with hearing impairment

• children who take any non-standard dietary supplements (i.e., apart from multi-vitamins), particularly any omega-3 FA, prior to starting the study

• children whose parents do not have an adequate understanding of English or French

Related Conditions & MeSH terms

• Language Disorders
• Language Impairment

Intervention

Dietary Supplement:
• Omega-3
800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
• Placebo
Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)

Locations

Country	Name	City	State
Canada	McGill University/Montreal Children's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Shuvo Ghosh

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over 3 months in learning assessed by a fast-mapping task	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.	Assessed at time of diagnosis and 3 months after intervention
Secondary	Feasibility of fish oil vs. chewable Concordix paste	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).	Given for 3 months as intervention