Autistic Disorder
Conditions
Keywords
Autism, Pregnancy, Newborn siblings
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.
Interventions
DRUGVitamin 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.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Who Developed Autism | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mothers Who Developed Side Effects From Vitamin D | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention During Pregnancy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Mothers with at least one child with autism, and pregnant before the third trimester | 20 participants |
| Region of Enrollment Israel | 1 participants |
| Region of Enrollment United States | 19 participants |
| Sex/Gender, Customized Females | 20 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
Population: Children who developed autism
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention During Pregnancy | Number of Children Who Developed Autism | 1 Children who developed autism |
Secondary
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
Population: The children born were assessed for whether they developed autism or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention During Pregnancy | Number of Mothers Who Developed Side Effects From Vitamin D | 0 participants |