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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Study of Vitamin D to Prevent Autism in Newborn Siblings|
- Autism or no autism develops [ Time Frame: Child assessed at 3 years of age ] [ Designated as safety issue: No ]The child will be screened by an MCHAT interview at 18 months of age, and by a questionnaire, the PDD Behavioral Inventory at 3 years of age to determine whether the child has developed autism or not.
- The mother or child will not develop side effects from vitamin D. [ Time Frame: During pregnancy and the 3 years of the child's development ] [ Designated as safety issue: Yes ]Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Drug: Vitamin D3
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 TV 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366885
|Contact: Kathy E. Henley, B.A.||email@example.com|
|Contact: Ervin G Stubbs, M.D.||firstname.lastname@example.org|
|United States, Oregon|
|Evergreen Center||Not yet recruiting|
|Oregon City, Oregon, United States, 97045|
|Sub-Investigator: John Green, M.D.|
|Principal Investigator:||Ervin G. Stubbs, M.D.||Oregon Health and Science University|