Vitamin D to Prevent Autism in Newborn Siblings

This study is not yet open for participant recruitment.
Verified May 2011 by Oregon Health and Science University
Sponsor:
Collaborator:
Autism Speaks
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01366885
First received: June 2, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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 Intervention Phase
Autistic Disorder
Drug: Vitamin D3
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Vitamin D to Prevent Autism in Newborn Siblings

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Autism or no autism develops [ Time Frame: Child assessed at 3 years of age ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The mother or child will not develop side effects from vitamin D. [ Time Frame: During pregnancy and the 3 years of the child's development ] [ Designated as safety issue: Yes ]
    Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Cholecalciferol
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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366885

Contacts
Contact: Kathy E. Henley, B.A. 503-351-9255 henleyjks@att.net
Contact: Ervin G Stubbs, M.D. 503-939-7351 stubbsg@ohsu.edu

Locations
United States, Oregon
Evergreen Center Not yet recruiting
Oregon City, Oregon, United States, 97045
Contact: Patt         
Sub-Investigator: John Green, M.D.         
Sponsors and Collaborators
Oregon Health and Science University
Autism Speaks
Investigators
Principal Investigator: Ervin G. Stubbs, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Gene Stubbs, M.D. Principal Investigator, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01366885     History of Changes
Other Study ID Numbers: OHSU-AS-11-1-11
Study First Received: June 2, 2011
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Autism
Pregnancy
Newborn siblings

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 23, 2014