DMSA Treatment of Children With Autism and Heavy Metal Toxicity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Determine the effect of DMSA therapy on the symptoms of autism
研究概览
简要总结
Many children with autism have a reduced level of glutathione and a reduced ability to excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair, provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an FDA-approved medication for treating lead poisoning in children, is effective in increasing excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic symptoms in some children with autism.
详细描述
This study will assess the safety and efficacy of the use of DMSA (an FDA-approved medication for treating lead poisoning in children) for the off-label treatment of symptoms of autism in children with autism and significant body burden of toxic metals.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with autism spectrum disorder
- •Age 3-8 years (up to the day before the ninth birthday).
- •At least a two-month history of taking a multi-vitamin/mineral supplement with at least the RDA of zinc, and continuing to take that during Phase One and Two.
- •Excretion of high amounts of toxic metals in phase one
- •Normal kidney/liver function, serum transaminases, and Complete Blood Count (CBC) (based on a blood test which will be conducted as part of Phase Two)
- •No changes in medication, supplements, diet, or behavioral interventions during the study
排除标准
- •Phase One and Two:
- •No mercury amalgam dental fillings.
- •No previous use of DMSA or other prescription chelators (except for 1-time challenges).
- •No anemia or currently being treated for anemia due to low iron.
- •No known allergies to DMSA
- •No liver or kidney disease
研究组 & 干预措施
DMSA- 1 round
Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo
干预措施: DMSA - dimercaptosuccinic acid (Drug)
DMSA-7 rounds
Participants receive 7 rounds of DMSA over 4 months; each round consists of 3 days of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 11 days off (no treatment), and then repeating.
干预措施: DMSA - dimercaptosuccinic acid (Drug)
结局指标
主要结局
Determine the effect of DMSA therapy on the symptoms of autism
时间窗: 4 month
Determine the safety of DMSA therapy by pre/post assessment of complete blood count, standard chem panel including liver/kidney function, and excretion of essential minerals
时间窗: 4 months
次要结局
- Determine if the initial severity of autism correlates with the excretion of toxic metals(1 month)