Clinical trial NCT01640106: Feasibility of Omega-3 Supplementation for Children With Language Impairments
Official title: Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Language Impairment
Keywords: Language
Fatty acids
Nutrition
Developmental delay
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 8
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change over 3 months in learning assessed by a fast-mapping task
timeFrame: Assessed at time of diagnosis and 3 months after intervention
Secondary outcomes:
measure: Feasibility of fish oil vs. chewable Concordix paste
timeFrame: Given for 3 months as intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University/Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: MUHC Montreal Children's Hospital
name: Shuvo Ghosh, MD
role: PRINCIPAL_INVESTIGATOR
References: