Vitamin D to Prevent Autism in Newborn Siblings

Autistic Disorder Clinical Trial

Official title:

Study of Vitamin D to Prevent Autism in Newborn Siblings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01366885
• Other study ID #: OHSU-AS-11-1-11
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 2, 2011
• Last updated: June 2, 2015
• Start date: December 2011
• Est. completion date: October 2017

Study information

• Verified date: May 2011
• Source: Oregon Health and Science University
• Contact: Kathy E. Henley, B.A.
• Phone: 503-351-9255
• Email: henleyjks[@]att.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 TV 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• Vitamin D3
4000 IU D3 capsule oral/day for entire pregnancy. 6000 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.

Locations

Country	Name	City	State
United States	Evergreen Center	Oregon City	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Autism Speaks

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism or no autism develops	The child will be screened by an MCHAT interview at 18 months of age, and by a questionnaire, the PDD Behavioral Inventory at 3 years of age to determine whether the child has developed autism or not.	Child assessed at 3 years of age	No
Secondary	The mother or child will not develop 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.	During pregnancy and the 3 years of the child's development	Yes