Vitamin/Mineral Supplement for Children and Adults With Autism

• ClinicalTrials.gov Identifier: NCT01225198
• Recruitment Status: Completed
• First Posted: October 20, 2010
• Last Update Posted: October 20, 2010
• Sponsor: Arizona State University
• Collaborators: Autism Research Institute; Legacy Foundation
• Information provided by: Arizona State University

Tracking Information

• First Submitted Date: September 14, 2010
• First Posted Date: October 20, 2010
• Last Update Posted Date: October 20, 2010
• Study Start Date: May 2008
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2010)

• Oxidative Stress [ Time Frame: Beginning of study (day 0) ]
  Level of Plasma Nitrotyrosine
• Oxidative Stress [ Time Frame: End of Study (after 12 weeks of treatment) ]
  Level of plasma nitrotyrosine

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 19, 2010)

Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ]

The Average Change of the Parent Global Impressions (PGI-R) assessment tool.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vitamin/Mineral Supplement for Children and Adults With Autism
• Official Title: New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Autism

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).

Study Arms

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

• Publications *: Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2010): 143
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01225198
• Other Study ID Numbers: AutismVitaminStudy2008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: James B. Adams, Arizona State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Arizona State University
• Original Study Sponsor: Same as current

Collaborators

• Autism Research Institute
• Legacy Foundation

Investigators

• Principal Investigator: James B. Adams, PhD; Arizona State University

• PRS Account: Arizona State University
• Verification Date: October 2010