Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior

PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Autism Spectrum Disorders
Interventions
DIETARY_SUPPLEMENT

Whey Protein

The experimental study group will consist of thirty children that will be treated with Immunocal® 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months to determine the supplement's effect in core areas of behavior in children with autism.

DIETARY_SUPPLEMENT

Rice Protein (Placebo)

The control or placebo study group will consist of thirty children that will be treated with rice protein (placebo) 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months.

Trial Locations (3)

33314

Mailman Segal Center, Fort Lauderdale

33328

Nova Southeastern University Clinic, Fort Lauderdale

Nova Southeastern University, College of Pharmacy, Fort Lauderdale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Immunotec Inc.

INDUSTRY

lead

Nova Southeastern University

OTHER