Vitamin D to Prevent Autism in Newborn Siblings
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|ClinicalTrials.gov Identifier: NCT01366885|
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : June 14, 2016
Last Update Posted : June 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: Vitamin D3||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Vitamin D to Prevent Autism in Newborn Siblings|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: 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.
Drug: 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.
Other Name: Cholecalciferol
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366885
|United States, Oregon|
|Oregon City, Oregon, United States, 97045|
|Principal Investigator:||Ervin G. Stubbs, M.D.||Oregon Health and Science University|