AutismNCT00889538
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
A study testing glutathione and glutathione, vit C and NAC in people with Autism and Severe Behavior Disorder, run by University of Louisville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Autism, Severe Behavior Disorder
- What is being tested?
- glutathione and glutathione, vit C and NAC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 to 16 years, inclusive
- Diagnosed with autism using the ADI-R (Autism Diagnostic Interview-Revised)
- ABC Irritability/Agitation subscale score (Aberrant Behavior Checklist Subscale) ≥ 18
- CGI-S score (Clinical Global Impression-Severity Scale) ≥ 4
- Must be drug naïve or on a stable dose of medication(s) and educational/behavioral interventions for one month prior to participation
- Parent/legal guardian must provide written consent and required research authorization (i.e. HIPAA) prior to the performance of any study procedures.
Who cannot join
- Presence of another disorder on the autism spectrum including PDD-NOS (Pervasive Developmental Disorder Not Otherwise Specified), Asperger's, and Rett's Syndrome
- Patient with a known cause of autism such as Fragile X
- Evidence of significant renal dysfunction (e.g. GFR estimated by the Schwartz formula < 50 mL/min or serum creatinine > 2.5 X upper limit of normal for age)
- Evidence of significant hepatic dysfunction (serum transaminases > 2.5 X the upper limit of normal)
- Known hypersensitivity to glutathione, vitamin C or NAC
- Pregnant or lactating female
Show all 9Show fewer
- Inability of subject and parent to be able to comply with requirements for study visits and procedures
- Presence of major mental illness
- History of antioxidant supplementation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Autism, Severe Behavior Disorder
- Being tested
- placebo, glutathione, glutathione, vit C and NAC
- Keywords
- Autism, Severe Behavior Disorder, Glutathione, Antioxidants
- Medical subject headings
- Autistic Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
50 mL of 1/2 normal saline IV
glutathioneDrug
glutathione 600 mg IV
glutathione, vit C and NACDrug
Also called NAC
Glutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) Receives: Drug: placebo |
| Glutathione | Active comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) Receives: Drug: glutathione |
| Glutathione, Vit C and NAC | Active comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) Receives: Drug: glutathione, vit C and NAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in both developmental skills and behavior with either glutathione or glutathione, Vitamin C and N-acetylcysteine therapy as compared to placebo therapy. Subjects will also be monitored using clinical and laboratory safety parameters.
Improvement in both developmental skills and behavior measured using validated scales in subjects receiving either glutathione, glutathione/Vitamin C/N-acetylcysteine or placebo measured at baseline, 9 weeks and at the end of study in a double-blind cross-over design.
Measured: 4 months
Secondary outcomes (3)
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Measured: Baseline
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Measured: 9 weeks
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Cumberland Pharmaceuticals, Norton Healthcare
- Responsible party
- Sponsor
- Investigators
- Patricia G. Williams, MD, Principal investigator, University of LouisvilleJanice E. Sullivan, M.D., Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889538
- Sponsor's protocol ID
- Glutathione-KCPCRU-01
- Status last verified
- Dec 2016
- First submitted
- 28 Apr 2009
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Crossover Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
- ClinicalTrials.gov ID
- NCT00889538
- Acronym / sponsor ID
- Glutathione-KCPCRU-01
- Conditions
- Autism, Severe Behavior Disorder
- Keywords
- Autism, Severe Behavior Disorder, Glutathione, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Cumberland Pharmaceuticals, Norton Healthcare
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboRandomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
| Glutathione | Active comparator | Drug: glutathioneRandomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
| Glutathione, Vit C and NAC | Active comparator | Drug: glutathione, vit C and NACRandomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 5 to 16 years, inclusive
- Diagnosed with autism using the ADI-R (Autism Diagnostic Interview-Revised)
- ABC Irritability/Agitation subscale score (Aberrant Behavior Checklist Subscale) ≥ 18
- CGI-S score (Clinical Global Impression-Severity Scale) ≥ 4
- Must be drug naïve or on a stable dose of medication(s) and educational/behavioral interventions for one month prior to participation
Key exclusion criteria (9 listed)
- Presence of another disorder on the autism spectrum including PDD-NOS (Pervasive Developmental Disorder Not Otherwise Specified), Asperger's, and Rett's Syndrome
- Patient with a known cause of autism such as Fragile X
- Evidence of significant renal dysfunction (e.g. GFR estimated by the Schwartz formula < 50 mL/min or serum creatinine > 2.5 X upper limit of normal for age)
- Evidence of significant hepatic dysfunction (serum transaminases > 2.5 X the upper limit of normal)
- Known hypersensitivity to glutathione, vitamin C or NAC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo50 mL of 1/2 normal saline IV | Drug | Placebo |
| glutathioneglutathione 600 mg IV | Drug | Glutathione |
| glutathione, vit C and NACAlso: NACGlutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL | Drug | Glutathione, Vit C and NAC |
Primary outcome
Improvement in both developmental skills and behavior with either glutathione or glutathione, Vitamin C and N-acetylcysteine therapy as compared to placebo therapy. Subjects will also be monitored using clinical and laboratory safety parameters.
Time frame: 4 months
Improvement in both developmental skills and behavior measured using validated scales in subjects receiving either glutathione, glutathione/Vitamin C/N-acetylcysteine or placebo measured at baseline, 9 weeks and at the end of study in a double-blind cross-over design.
3 secondary outcomes
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: Baseline
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: 9 weeks
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia G. Williams, MD principal investigator
University of Louisville
Janice E. Sullivan, M.D. study director
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glutathione and glutathione, vit C and NAC in people with Autism and Severe Behavior Disorder, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in both developmental skills and behavior with either glutathione or glutathione, Vitamin C and N-acetylcysteine therapy as compared to placebo therapy. Subjects will also be monitored using clinical and laboratory safety parameters. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.