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Completed

NCT Number: NCT01366885

Vitamin D to Prevent Autism in Newborn Siblings

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.

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Key information

Conditions

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

Age range

20 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Evergreen Center

Oregon City, Oregon, 97045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cholecalciferol

Primary outcomes

  1. Number of Children Who Developed Autism

    Time frame: 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 outcomes

  1. Number of Mothers Who Developed Side Effects From Vitamin D

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Study of Vitamin D to Prevent Autism in Newborn Siblings

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2011
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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