Vitamin D to Prevent Autism in Newborn Siblings

NCT01366885 | Completed Phase 2 Results DMC

• 1 other identifier: OHSU-AS-11-1-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Keywords

Autism; Pregnancy; Newborn siblings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Mothers Who Developed Side Effects From Vitamin D

  During pregnancy and the 3 years of the child's development

Study Arms (1)

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.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Also known as: Cholecalciferol

Intervention during pregnancy

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Evergreen Center

Oregon City, Oregon, 97045, United States

Location

Related Publications (1)

• Cannell JJ. On the aetiology of autism. Acta Paediatr. 2010 Aug;99(8):1128-30. doi: 10.1111/j.1651-2227.2010.01883.x. Epub 2010 May 19. No abstract available.

  PMID: 20491697 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Gene Stubbs
• Organization: OHSU

stubbsgene@comcast.net

503-939-7351

Study Officials

• Ervin G. Stubbs, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Emeritus of Psychiatry and Pediatrics

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: February 1, 2008
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 14, 2016
• Results First Posted: June 14, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)