Vitamin/Mineral Supplement for Children and Adults With Autism

Arizona State University (ASU)

Status and phase: Completed; Phase 2

Conditions: Autism

Treatments: Dietary Supplement: Multi-Vitamin/Mineral Supplement; Other: Liquid Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01225198

AutismVitaminStudy2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 3 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Liquid Placebo

Vitamin/Mineral Supplement Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Multi-Vitamin/Mineral Supplement