Vitamin/Mineral Supplement for Children and Adults With Autism

NCT01225198 | Completed Phase 2

• 1 other identifier: AutismVitaminStudy2008
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.improvement of nutritional status in some children/adults with autism, and
2. 2.reduction of some of the symptoms of autism in some children

Conditions

Autism

Keywords

Vitamins; Minerals

Outcome Measures

Primary Outcomes (2)

• Oxidative Stress

  Level of Plasma Nitrotyrosine

  Beginning of study (day 0)

• Oxidative Stress

  Level of plasma nitrotyrosine

  End of Study (after 12 weeks of treatment)

Secondary Outcomes (1)

• Parent Global Impressions - Revised

  End of study (12 weeks)

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Liquid placebo with identical packaging and flavoring to the real supplement.

Other: Liquid Placebo

Vitamin/Mineral Supplement Group

EXPERIMENTAL

Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.

Dietary Supplement: Multi-Vitamin/Mineral Supplement

Interventions

Multi-Vitamin/Mineral Supplement DIETARY_SUPPLEMENT

A broad-spectrum vitamin/mineral supplement designed for children and adults with autism

Vitamin/Mineral Supplement Group

Liquid Placebo OTHER

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).

Placebo Group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 3-60 years old;
• Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
• 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

You may not qualify if:

• Usage of a vitamin/mineral supplement in the last 2 months
• Current use of any chelation treatment

Sponsors & Collaborators

• Arizona State University: lead
• Autism Research Institute: collaborator
• Legacy Foundation: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Publications (1)

• 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.

  PMID: 22151477 DERIVED

Related Links

• Arizona State University Autism/Asperger's Research Program

MeSH Terms

Conditions

Autistic Disorder

Interventions

Geritol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James B. Adams, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: October 20, 2010
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 20, 2010

Record last verified: 2010-10

Locations

US (1)