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UCSF Trial of Vitamin D and Autism Will Recruit Ages 3-8

  [ 3 votes ]   [ Post a Comment ]
www.ProHealth.com • October 12, 2011


The University of California San Francisco has a Very Active Autism Clinic and Autism & Neurodevelopment Research Program (http://anp.ucsf.edu/aboutus)

This clinic/research center frequently begins new autism studies and clinical trials for which you or your child might be eligible – and invite those interested to complete a confidential Contact Form as a first step (complete it online, or print it out and complete, fax or mail). Your submitted form will allow the researchers to contact you with information about research studies.

One simple but potentially important trial (which is just awaiting final approval and will be actively recruiting children ages 3-8 soon, according to the coordinator), is:

AUTISM TRIAL WITH VITAMIN D (free, 4 months, 4 visits)
(http://anp.ucsf.edu/research/trials/vitamind)

Summary

Study director: http://profiles.ucsf.edu/ProfileDetails.aspx?Person=5241805 Robert Hendren, DO

Sponsor: Ddrops [vitamin D3]

Recruiting?: Not currently (October 12), but it will begin actively recruiting soon

Official study title:
Open Label Clinical Trial of Vitamin D3 Dosage Tolerability and Effect on Behavioral Measures in Children with Autism

ClinicalTrials.gov identifier: Pending

Conditions studied:
Autistic disorder

Intervention:
Vitamin D3 (cholecalciferol)

Phase:
Phase II

Purpose: To observe the effects of Vitamin D supplementation on standard behavior measures in a small sample size of children with autism. The results will indicate whether a double blind placebo controlled trial with a larger sample size would be a worthwhile option.

Eligibility

Inclusion criteria:

• Child is 3-8 years old

• Child has a diagnosis of autistic disorder

• Child did not have developmental delays before the age of 12 months

• Child has CGI-S score of at least 4, but less than 7 at the Screening and Baseline visits

• English must be primary language of child

Exclusion criteria:
[Disqualifying factors are…]

Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder

Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X Syndrome

History of neuroleptic malignant syndrome

A seizure within the past year

History of severe head trauma or stroke

History or current evidence of any unstable medical conditions

History of kidney or liver disease

Known bleeding disorder, or history of failure to clot

History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia

Known granulomatous disease (tuberculosis, sarcoidosis)

Child may not be taking any psychoactive medications currently

Taking the following medications or supplements: Cod-liver oil, Vitamin A, Thiazide Diuretics, Calcipotriene, Digoxin, Diltiazem, Verapamil, Cimetidine, Heparin

What is involved?

Testing: Behavioral assessments, cognitive testing, parent questionnaires, physical examinations, blood specimen collection, and vital signs

Frequency of visits:
The study lasts 12 weeks and will involve 4 visits to UCSF, each visit about four weeks apart

Materials needed prior to evaluation: None

Costs: No costs will be charged for any of the study procedures

Contact Information


Coordinator: Felicia Widjaja – felicia.widjaja@ucsf.edu, (415) 476-7803




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