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Vitamin D to Prevent Autism in Newborn Siblings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gene Stubbs, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01366885
First received: June 2, 2011
Last updated: May 5, 2016
Last verified: May 2016
  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: 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:
  • Number of Children Who Developed Autism [ Time Frame: Child assessed at 3 years of age ] [ Designated as safety issue: No ]
    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:
  • Number of Mothers Who Developed 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.


Enrollment: 20
Study Start Date: February 2008
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 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.
  Eligibility

Ages Eligible for Study:   20 Years to 44 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
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
  More Information

Publications:
Responsible Party: Gene Stubbs, Associate Professor Emeritus of Psychiatry and Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01366885     History of Changes
Other Study ID Numbers: OHSU-AS-11-1-11 
Study First Received: June 2, 2011
Results First Received: April 2, 2016
Last Updated: May 5, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Please see publication in Medical Hypotheses-88(2016) 74-78-entitled: Autism: Will vitamin D Supplementation during pregnancy and early childhood reduce the recurrence rate of autism in newborn siblings? G. Stubbs et al.

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

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

ClinicalTrials.gov processed this record on September 23, 2016