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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692315
Other study ID # 28839
Secondary ID
Status Completed
Phase N/A
First received June 4, 2008
Last updated April 13, 2016
Start date September 2006
Est. completion date December 2007

Study information

Verified date April 2016
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

An open label trial was undertaken in 40 autistic children to determine whether treatment with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores were measured before and after a three month intervention period.

The results indicated that pre-treatment metabolites in autistic children were significantly different from values in age-matched control children. The three month intervention resulted in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p < 0.001). The oxidized disulfide form of glutathione (GSSG) was decreased (p < 0.008) and the glutathione redox ratio (GSH/GSSG) was increased after treatment (p < 0.001). Although significantly improved, these metabolites remained below control levels after intervention (p > 0.01). Similarly, increases in VABS composite score and sub-scores for Socialization, Communication, and Daily Living Skills increased after treatment (p < 0.007) but also remained below standard scores.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Autistic Disorder by DSM-IV 299.0 or CARS score >30

Exclusion Criteria:

- Primary genetic disease with co-morbid autism

- frequent seizures

- recent surgery

- active infection with fever

- high dose vitamin/mineral supplements

- severe gastrointestinal symptoms

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Methylcobalamin (methylB12)
75 ug/Kg methylB12 every 3 days by subcutaneous injection

Locations

Country Name City State
United States Arkansas Children's Hospital Research Institute Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glutathione redox status (GSH/GSSG) HPLC analysis 3 months No
Secondary Vineland Adaptive Behavior Scales Behavior measure 3 months No
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