Vitamin D to Prevent Autism in Newborn Siblings

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Autistic Disorder

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01366885

OHSU-AS-11-1-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention during pregnancy

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D3