Fatty Acid Supplements Alter Biological Signatures in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sarah Keim
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety (Adverse Events)
研究概览
简要总结
The purpose of this study is to examine how fatty acid supplementation alters biological signatures in children with ASD
详细描述
Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms that affect their quality of life and severely disrupt family well-being. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses were formulated based on data from the investigators previous studies and other published data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently elevated in children with ASD and decreases in these markers correlate with ASD symptom improvement. The investigators long-term goal is to identify effective treatments for ASD.
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)
盲法说明
Quadruple
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
- •ADOS-2 score in "autism" (severe) range
- •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
- •Quadriparesis
- •Blindness
- •Seizure disorder diagnosis
- •Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes, Tuberous Schlerosis
- •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
LCPUFA Oil Supplement, Low Dose
25 mg/kg of GLA+EPA+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)
LCPUFA Oil Supplement, Medium Dose
50 mg/kg of GLA+EPA+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)
LCPUFA Oil Supplement, High Dose
75 mg/kg of GLA+EPA+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
Safety (Adverse Events)
时间窗: Baseline to 90 days post-randomization
Average number of adverse events per treatment group
Bioavailability
时间窗: Baseline to 90 days post-randomization
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Biological Signatures
时间窗: Baseline to 90 days post-randomization
Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.
次要结局
未报告次要终点
研究者
Sarah Keim
Principal Investigator
Nationwide Children's Hospital