Autism Clinical Trial
Official title:
Double-Blind, Placebo-Controlled, Crossover Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems. The investigators hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
This is a prospective, single center, double-blind, randomized pilot study in children and adolescents with autism and severe behavior disorders. All subjects will undergo initial screening procedures to determine eligibility. They will then be randomized to either 8 weeks of placebo or 8 weeks of glutathione or glutathione, vitamin C and N-acetylcysteine. They will receive intravenous treatment weekly and will have ongoing behavioral studies during this period. Following 8 weeks of therapy, they will have a week without treatment then will cross-over to the alternate therapy for weekly intravenous infusions and behavioral testing. In addition to baseline hematology and chemistries, baseline oxidized and reduced glutathione will be measured. These parameters will be repeated at the end of each 8 week course of therapy. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
| Completed |
NCT04167839 -
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
|
N/A | |
| Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06080087 -
Implementation Toolkit to Enhance EBP Among Marginalized Families
|
N/A | |
| Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
| Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
| Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
| Completed |
NCT05588570 -
Coaching Children With Anxiety and Autism Through Telehealth
|
N/A | |
| Enrolling by invitation |
NCT06058104 -
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism
|
N/A | |
| Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02847182 -
Cord Blood Infusion for Children With Autism Spectrum Disorder
|
Phase 2 | |
| Withdrawn |
NCT02414451 -
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
|
N/A | |
| Completed |
NCT03002363 -
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
|
Phase 1 | |
| Completed |
NCT02536365 -
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
|
N/A | |
| Completed |
NCT02720900 -
Prebiotic Intervention for Autism Spectrum Disorders
|
N/A | |
| Completed |
NCT02508922 -
Trial of Vitamin D3 Supplementation in Paediatric Autism
|
N/A | |
| Completed |
NCT02708290 -
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
|
||
| Recruiting |
NCT01836562 -
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
| Completed |
NCT02154828 -
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
|