A Phase 2 interventional study of Vitamin D3 in Autistic Disorder, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2016-06-14.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Prevention
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.
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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
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Exclusion Criteria:
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.
Also known as: Cholecalciferol
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.
Time frame: Child assessed at 3 years of age
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.
Time frame: During pregnancy and the 3 years of the child's development
| Milestone | Intervention During Pregnancy |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
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.
| Children who developed autism | Intervention During Pregnancy |
|---|---|
| Number of Children Who Developed Autism | 1 |
Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.
| participants | Intervention During Pregnancy |
|---|---|
| Number of Mothers Who Developed Side Effects From Vitamin D | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention During Pregnancy | — | 0/19 (0%) | 0/19 (0%) |
Mothers of at least one child with autism and pregnant before the third trimester
| Age, Categorical(Participants) | Intervention During Pregnancy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex/Gender, Customized(participants) | Intervention During Pregnancy |
|---|---|
| Females | 20 |
| Region of Enrollment(participants) | Intervention During Pregnancy |
|---|---|
| United States | 19 |
| Israel | 1 |
| Mothers with at least one child with autism, and pregnant before the third trimester(participants) | Intervention During Pregnancy |
|---|---|
| Number | 20 |
Plan to share: Yes — 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.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Oregon Health and Science University →