Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment very difficult; only preliminary data usable.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Experimental | Treatment arm, using the omega-3 product (fish oil/paste) |
|
| Control | Placebo Comparator | Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | 800 mg Omega 3 daily (600 mg DHA/200 mg EPA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shuvo Ghosh, MD | MUHC Montreal Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University/Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D007802 | Language |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA) |
|
| Given for 3 months as intervention |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003142 | Communication |
| D001519 | Behavior |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |