Study of Vitamin D to Prevent Autism in Newborn Siblings
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Children Who Developed Autism
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant mothers who have had at least one child with autism spectrum disorder
Exclusion Criteria
- •Child with autism must not be from a syndrome such as Fragile X syndrome, Retts Syndrome
- •Mother must be before the third trimester
Arms & Interventions
Intervention during pregnancy
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.
Intervention: Vitamin D3 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Mothers Who Developed Side Effects From Vitamin D(During pregnancy and the 3 years of the child's development)
Investigators
Gene Stubbs
Associate Professor Emeritus of Psychiatry and Pediatrics
Oregon Health and Science University