Vitamin D to Prevent Autism in Newborn Siblings

Phase 2

Completed

• Conditions: Autistic Disorder
• Interventions: Drug: Vitamin D3

• Registration Number: NCT01366885
• Lead Sponsor: Oregon Health and Science University

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2016-04-02
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Results First Posted: 2016-06-14
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention during pregnancy	Vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
Number of Children Who Developed Autism	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 Outcome Measures

Name	Time	Method
Number of Mothers Who Developed Side Effects From Vitamin D	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.

Trial Locations

Locations (1)

Evergreen Center; 🇺🇸 Oregon City, Oregon, United States