Vitamin D to Prevent Autism in Newborn Siblings

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01366885
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 96
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Drug: Vitamin D3	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Study of Vitamin D to Prevent Autism in Newborn Siblings
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Other Names: Cholecalciferol

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 44 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Evergreen Center	Oregon City	Oregon	United States	97045

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: Ervin G. Stubbs, M.D., Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cannell JJ. On the aetiology of autism. Acta Paediatr. 2010 Aug;99(8):1128-30. doi: 10.1111/j.1651-2227.2010.01883.x. Epub 2010 May 19.

• Responsible Party: Gene Stubbs, Associate Professor Emeritus of Psychiatry and Pediatrics, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01366885
• Other Study ID Numbers: OHSU-AS-11-1-11
• First Posted: Jun 6, 2011
• Last Update Posted: Jun 14, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Gene Stubbs, Associate Professor Emeritus of Psychiatry and Pediatrics, Oregon Health and Science University: Autism; Pregnancy; Newborn siblings
• Additional relevant MeSH terms: Autistic Disorder; Vitamin D; Cholecalciferol

Study Results

Participant Flow

Arm/Group Title	Intervention During Pregnancy
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
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Intervention During Pregnancy
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 Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex/Gender, Customized (participants) [Number]
Females	20 100%
Region of Enrollment (participants) [Number]
United States	19 95%
Israel	1 5%
Mothers with at least one child with autism, and pregnant before the third trimester (participants) [Number]
Number [participants]	20 100%

Outcome Measures

1. Primary Outcome

Title	Number of Children Who Developed Autism
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

Outcome Measure Data

Analysis Population Description

Children who developed autism

Arm/Group Title	Intervention During Pregnancy
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.
Measure Participants	19
Number [Children who developed autism]	1

2. Secondary Outcome

Title	Number of Mothers Who Developed Side Effects From Vitamin D
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

Outcome Measure Data

Analysis Population Description

The children born were assessed for whether they developed autism or not.

Arm/Group Title	Intervention During Pregnancy
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.
Measure Participants	19
Number [participants]	0 0%

Adverse Events

Arm/Group Title	Intervention During Pregnancy
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intervention During Pregnancy
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Intervention During Pregnancy
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.