Vitamin D to Prevent Autism in Newborn Siblings

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autistic Disorder

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention during pregnancy<br>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. | Drug: Vitamin D3<br>* 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age.<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Children Who Developed Autism | 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. | Child assessed at 3 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Mothers Who Developed Side Effects From Vitamin D | Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D. | During pregnancy and the 3 years of the child's development | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Pregnancy, Newborn siblings