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临床试验/NCT00692315
NCT00692315已完成不适用

Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism

Arkansas Children's Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Glutathione redox status (GSH/GSSG)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Primary genetic disease with co-morbid autism
  • frequent seizures
  • recent surgery
  • active infection with fever
  • high dose vitamin/mineral supplements
  • severe gastrointestinal symptoms

研究组 & 干预措施

Methyl B12

Experimental

Subcutaneous injection of 75 micrograms/Kg

干预措施: Methylcobalamin (methylB12) (Drug)

Folinic Acid

Experimental

400 micrograms orally twice a day

干预措施: Methylcobalamin (methylB12) (Drug)

结局指标

主要结局

Glutathione redox status (GSH/GSSG)

时间窗: 3 months

HPLC analysis

次要结局

  • Vineland Adaptive Behavior Scales(3 months)

研究者

研究点 (1)

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