Trial Outcomes & Findings for Vitamin D to Prevent Autism in Newborn Siblings (NCT NCT01366885)
NCT ID: NCT01366885
Last Updated: 2016-06-14
Results Overview
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.
COMPLETED
PHASE2
20 participants
Child assessed at 3 years of age
2016-06-14
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
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19
|
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D to Prevent Autism in Newborn Siblings
Baseline characteristics by cohort
| Measure |
Intervention During Pregnancy
n=20 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Females
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20 participants
n=99 Participants
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Region of Enrollment
United States
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19 participants
n=99 Participants
|
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Region of Enrollment
Israel
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1 participants
n=99 Participants
|
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Mothers with at least one child with autism, and pregnant before the third trimester
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20 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Child assessed at 3 years of agePopulation: 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.
Outcome measures
| Measure |
Intervention During Pregnancy
n=19 Participants
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.
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|---|---|
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Number of Children Who Developed Autism
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1 Children who developed autism
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SECONDARY outcome
Timeframe: During pregnancy and the 3 years of the child's developmentPopulation: The children born were assessed for whether they developed autism or not.
Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.
Outcome measures
| Measure |
Intervention During Pregnancy
n=19 Participants
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.
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|---|---|
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Number of Mothers Who Developed Side Effects From Vitamin D
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0 participants
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Adverse Events
Intervention During Pregnancy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place