Feasibility of Omega-3 Supplementation for Children With Language Impairments

Shuvo Ghosh

Status: Terminated

Conditions: Language Impairment

Treatments: Dietary Supplement: Omega-3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01640106

09-164-PED

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 24 to 42 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

8 participants in 2 patient groups, including a placebo group

Omega-3

Experimental group

Description:

Treatment arm, using the omega-3 product (fish oil/paste)

Treatment:

Dietary Supplement: Omega-3

Control

Placebo Comparator group

Description:

Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste

Treatment:

Dietary Supplement: Placebo