Vitamin/Mineral Supplement for Children and Adults With Autism

Autism Clinical Trial

Official title:

New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225198
• Other study ID #: AutismVitaminStudy2008
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: October 19, 2010
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2010
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

1. improvement of nutritional status in some children/adults with autism, and

2. reduction of some of the symptoms of autism in some children

Description:

The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 60 Years

Eligibility

Inclusion Criteria:

1. age 3-60 years old;

2. Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional

3. Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report

Exclusion Criteria:

1. Usage of a vitamin/mineral supplement in the last 2 months

2. Current use of any chelation treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• Multi-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism

Other:
• Liquid Placebo
The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Autism Research Institute, Legacy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative Stress	Level of Plasma Nitrotyrosine	Beginning of study (day 0)	Yes
Primary	Oxidative Stress	Level of plasma nitrotyrosine	End of Study (after 12 weeks of treatment)	Yes
Secondary	Parent Global Impressions - Revised	The Average Change of the Parent Global Impressions (PGI-R) assessment tool.	End of study (12 weeks)	Yes

External Links

•   Arizona State University Autism/Asperger's Research Program