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临床试验/NCT01366885
NCT01366885已完成2 期

Study of Vitamin D to Prevent Autism in Newborn Siblings

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of Children Who Developed Autism

研究概览

简要总结

The purpose of this study is to determine whether by administering vitamin D to mothers who already have at least one child with autism and who are pregnant, that the vitamin D will prevent the recurrence of autism in the newborn sibling.

详细描述

The incidence of autism is increasing. Also, women of childbearing age are increasingly found to be insufficient/deficient in vitamin D. Vitamin D is a neurohormone which is important for development of the child, especially of the child's brain. The primary source of vitamin D is from the sun through one's skin. People have been avoiding the sun because of skin cancer, because of increasing Television watching, computer viewing and wearing clothes that cover most of the body. This approach will study whether making the pregnant mother, whose child is at risk for autism because of a previous child with autism, replete with vitamin D will prevent that recurrence of autism in the newborn sibling.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant mothers who have had at least one child with autism spectrum disorder

排除标准

  • Child with autism must not be from a syndrome such as Fragile X syndrome, Retts Syndrome
  • Mother must be before the third trimester

研究组 & 干预措施

Intervention during pregnancy

Experimental

5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.

干预措施: Vitamin D3 (Drug)

结局指标

主要结局

Number of Children Who Developed Autism

时间窗: Child assessed at 3 years of age

The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not.

次要结局

  • Number of Mothers Who Developed Side Effects From Vitamin D(During pregnancy and the 3 years of the child's development)

研究者

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

Gene Stubbs

Associate Professor Emeritus of Psychiatry and Pediatrics

Oregon Health and Science University

研究点 (1)

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