Vitamin D to Prevent Autism in Newborn Siblings
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional prevention trial for Autistic Disorder focused on measuring Autism, Pregnancy, Newborn siblings
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
Sites / Locations
- Evergreen Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention during pregnancy
Arm 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.
Outcomes
Primary Outcome Measures
Number of Children Who Developed Autism
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 Outcome Measures
Number of Mothers Who Developed Side Effects From Vitamin D
Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.
Full Information
NCT ID
NCT01366885
First Posted
June 2, 2011
Last Updated
May 5, 2016
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01366885
Brief Title
Vitamin D to Prevent Autism in Newborn Siblings
Official Title
Study of Vitamin D to Prevent Autism in Newborn Siblings
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Pregnancy, Newborn siblings
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention during pregnancy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Children Who Developed Autism
Description
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.
Time Frame
Child assessed at 3 years of age
Secondary Outcome Measure Information:
Title
Number of Mothers Who Developed Side Effects From Vitamin D
Description
Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.
Time Frame
During pregnancy and the 3 years of the child's development
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ervin G. Stubbs, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreen Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Please see publication in Medical Hypotheses-88(2016) 74-78-entitled: Autism: Will vitamin D Supplementation during pregnancy and early childhood reduce the recurrence rate of autism in newborn siblings? G. Stubbs et al.
Citations:
PubMed Identifier
20491697
Citation
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.
Results Reference
background
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Vitamin D to Prevent Autism in Newborn Siblings
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