Vitamin D to Prevent Autism in Newborn Siblings
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Autistic Disorder |
Drug: Vitamin D3 |
Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 40 |
| 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.
Eligibility| Ages Eligible for Study: | 20 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kathy E. Henley, B.A. | 503-351-9255 | henleyjks@att.net |
| Contact: Ervin G Stubbs, M.D. | 503-939-7351 | stubbsg@ohsu.edu |
| United States, Oregon | |
| Evergreen Center | Not yet recruiting |
| Oregon City, Oregon, United States, 97045 | |
| Contact: Patt | |
| Sub-Investigator: John Green, M.D. | |
| Principal Investigator: | Ervin G. Stubbs, M.D. | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Gene Stubbs, M.D. Principal Investigator, Oregon Health & Science University |
| ClinicalTrials.gov Identifier: | NCT01366885 History of Changes |
| Other Study ID Numbers: | OHSU-AS-11-1-11 |
| Study First Received: | June 2, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Autism Pregnancy Newborn siblings |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Cholecalciferol Vitamin D Ergocalciferols |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 23, 2013