Vitamin/Mineral Supplement for Children and Adults With Autism

Phase 2

Completed

• Conditions: Autism
• Interventions: Other: Liquid Placebo; Dietary Supplement: Multi-Vitamin/Mineral Supplement

• Registration Number: NCT01225198
• Lead Sponsor: Arizona State University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2010-09-14
• Status Verified: 2010-10
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Liquid Placebo	Liquid placebo with identical packaging and flavoring to the real supplement.
Vitamin/Mineral Supplement Group	Multi-Vitamin/Mineral Supplement	Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.

Primary Outcome Measures

Name	Time	Method
Oxidative Stress	End of Study (after 12 weeks of treatment)	Level of plasma nitrotyrosine

Secondary Outcome Measures

Name	Time	Method
Parent Global Impressions - Revised	End of study (12 weeks)	The Average Change of the Parent Global Impressions (PGI-R) assessment tool.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States