Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 37 for:    Developmental Disabilities | ( Map: Oregon, United States )

Vitamin D to Prevent Autism in Newborn Siblings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01366885
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Gene Stubbs, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Autistic Disorder
Intervention Drug: Vitamin D3
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention During Pregnancy
Hide Arm/Group 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.

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.

Period Title: Overall Study
Started 20 [1]
Completed 19 [2]
Not Completed 1
[1]
We started recruiting in February 2008 and recruited 20 mothers.
[2]
We completed our study when the last child born had reached 36 months of age.
Arm/Group Title Intervention During Pregnancy
Hide Arm/Group 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.

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Mothers of at least one child with autism and pregnant before the third trimester
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Females Number Analyzed 20 participants
20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
United States 19
Israel 1
Mothers with at least one child with autism, and pregnant before the third trimester  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Children Who Developed Autism
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Children who developed autism
Arm/Group Title Intervention During Pregnancy
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Children who developed autism
1
2.Secondary Outcome
Title Number of Mothers Who Developed Side Effects From Vitamin D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The children born were assessed for whether they developed autism or not.
Arm/Group Title Intervention During Pregnancy
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention During Pregnancy
Hide Arm/Group 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.

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.

All-Cause Mortality
Intervention During Pregnancy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention During Pregnancy
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention During Pregnancy
Affected / at Risk (%)
Total   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gene Stubbs
Organization: OHSU
Phone: 503-939-7351
Responsible Party: Gene Stubbs, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01366885     History of Changes
Other Study ID Numbers: OHSU-AS-11-1-11
First Submitted: June 2, 2011
First Posted: June 6, 2011
Results First Submitted: April 2, 2016
Results First Posted: June 14, 2016
Last Update Posted: June 14, 2016