NCT01640106

Feasibility of Omega-3 Supplementation for Children With Language Impairments

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Shuvo Ghosh · Academic / Other
• Sex: All
• Age: 24 Months – 42 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Language Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
DIETARY_SUPPLEMENT	Placebo	Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-03-01
• Completion: 2015-06-01
• First posted: 2012-07-13
• Last updated: 2019-09-09

Locations

1 site across 1 country: Canada