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临床试验/NCT03162445
NCT03162445已完成不适用

Bone Mass Accrual in Children With Autism Spectrum Disorder

Massachusetts General Hospital0 个研究点目标入组 49 人开始时间: 2010年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
主要终点
Bone Mineral Density

研究概览

简要总结

This is a observational study to investigate the degree to which bone mineral density is impaired in boys with autism compared with typically developing controls.

详细描述

Studies have shown that bone cortical thickness is decreased in children with autism and other developmental disabilities. However it is not known whether bone mineral density (BMD) of these children is lower; neither is it known whether there is any correlation between BMD and the child's diet. The overall goal of this study is to improve the long term health of children and adolescents with autism spectrum disorder; more specifically the investigators aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with autism and to explore specific additional risk factors. In addition, the aim is to investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD) and to explore specific contributing risk factors including nutritional analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Boys 8-17 years chronological age
  • BMI between the 3rd and 97th percentiles
  • Meets DSM-IV criteria for Autism Spectrum Disorder (ASD group)
  • Scores <15 on the Social Communication Questionnaire (control group)

排除标准

  • Use of medications directly affecting bone metabolism including estrogen/ progesterone preparations and glucocorticoids except local application of glucocorticoid
  • Use of anticonvulsants which affect bone density including diphenylhydantoin, phenobarbital, topiramate carbamazepine and valproic acid and also use of lithium
  • Children with diseases known to affect bone mineral density including Crohn's disease, celiac, thyroid and renal
  • Children who will not tolerate lying still for 30 seconds

结局指标

主要结局

Bone Mineral Density

时间窗: Bone mineral density will be assessed within one month of enrolling in the study.

using dual energy x-ray absorptiometry (DXA) (Hologic Discovery A, Software Version: APEX 4.0.2, Bedford, MA USA) at the total hip, femoral neck, lumbar spine (L1-4), whole body and whole body less head bone mineral density.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Neumeyer

Assistant Professor Neurology

Massachusetts General Hospital

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