Vitamin D to Prevent Autism in Newborn Siblings

NCT ID: NCT01366885

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2016-02-29

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.

Conditions

Autistic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: 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.

Interventions

Vitamin D3

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.

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Gene Stubbs

Associate Professor Emeritus of Psychiatry and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ervin G. Stubbs, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Evergreen Center

Oregon City, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20491697 (View on PubMed)

Other Identifiers

OHSU-AS-11-1-11

Identifier Type: -

Identifier Source: org_study_id