Clinical Trial: Vitamin D to Prevent Autism in Newborn Siblings

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Vitamin D to Prevent Autism in Newborn Siblings

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: Number of Children Who Developed Autism [ Time Frame: 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.


Original Primary Outcome: Autism or no autism develops [ Time Frame: Child assessed at 3 years of age ]

The child will be screened by an MCHAT interview at 18 months of age, and by a questionnaire, the PDD Behavioral Inventory at 3 years of age to determine whether the child has developed autism or not.


Current Secondary Outcome: Number of Mothers Who Developed Side Effects From Vitamin D [ Time Frame: During pregnancy and the 3 years of the child's development ]

Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.


Original Secondary Outcome: The mother or child will not develop side effects from vitamin D. [ Time Frame: During pregnancy and the 3 years of the child's development ]

Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.


Information By: Oregon Health and Science University

Dates:
Date Received: June 2, 2011
Date Started: February 2008
Date Completion:
Last Updated: May 5, 2016
Last Verified: May 2016