Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sarah Keim
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
研究概览
简要总结
The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms.
详细描述
Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-6 years old
- •ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- •English is primary language
排除标准
- •Fatty acid supplementation in the past 6 months
- •Consumes fatty fish more than 3 times per week
- •Still breastfeeding or formula feeding
- •Bleeding disorder
- •Quadriparesis
- •Blindness
- •Seizure disorder diagnosis
- •Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis
- •Feeding problems precluding consumption of the supplement
- •Ingredient allergy (canola, fish, or borage seed)
- •Planned surgeries scheduled within the time frame of trial participation
研究组 & 干预措施
Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement
25 mg/kg, 50 mg/kg, or 75 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days
干预措施: LCPUFA Oil Supplement (Drug)
Canola Oil
Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
干预措施: Canola Oil Placebo (Dietary Supplement)
结局指标
主要结局
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
时间窗: Baseline to 90 days post randomization.
Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.
次要结局
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite(Baseline to 90 days post randomization (End of Trial))
- Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems(Baseline to 90 days post randomization.)
- Preschool Language Scales - 5 (PLS-5) Auditory Comprehension(Baseline to 90 days post randomization.)
- Childhood Autism Rating Scale (CARS2) (2nd ed.)(Baseline to 90 days post randomization.)
- Autism Impact Measure - Total(Baseline to 90 days post randomization.)
- Preschool Language Scales-5 Expressive Communication(Baseline (day 0) to end of trial (90 days))
- Preschool Language Scales-5 Total Language(Baseline (day 0) to end of trial (90 days))
- Autism Impact Measure - Restricted Behavior(Baseline to 90 days post randomization.)
- Autism Impact Measure - Communication(Baseline to 90 days post randomization.)
- Autism Impact Measure - Atypical Behavior(Baseline to 90 days post randomization.)
- Autism Impact Measure - Social Reciprocity(Baseline to 90 days post randomization.)
- Autism Impact Measure - Peer Interaction(Baseline to 90 days post randomization.)
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication(Baseline to 90 days post randomization (End of Trial))
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization(Baseline to 90 days post randomization (End of Trial))
研究者
Sarah Keim
Principal Investigator
Nationwide Children's Hospital