Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Shuvo Ghosh
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change over 3 months in learning assessed by a fast-mapping task
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change over 3 months in learning assessed by a fast-mapping task
时间窗: Assessed at time of diagnosis and 3 months after intervention
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.
次要结局
- Feasibility of fish oil vs. chewable Concordix paste(Given for 3 months as intervention)
研究者
Shuvo Ghosh
Assistant Professor of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre