Joseph A. Bellanti, M.D., Principal Investigator
Glen Elliott, M.D., PhD., Principal Investigator, UCSF
Dawn B. Wallerstedt, RN, MSN, FNP, Clinical Research Coordinator

The purpose of this multi-center research study is to compare the effect of targeted dietary restrictions and nutritional supplementation on behavioral outcomes in young children with ADHD.

The rationale of this study is based upon the hypothesis that the pathogenesis of ADHD, in some children, may be based upon mediator-induced neurologic dysfunction related to foods (particularly milk, dairy products and wheat, food additives, coloring agents and sugar) and that the elimination of these agents coupled with a nutritional supplement may reverse or decrease the symptoms of ADHD.

The study design includes two double-blinded Ritalin titration trials from Week 1-4 and again from Week 17-20. Following this, subjects will be randomly assigned to one of two groups: 1) Diet 1 in which dairy products, wheat, sugar, food additives, coloring agents and preservatives are eliminated and 2) Diet 2 in which organochlorine pesticide derivatives (found in red meat, fatty fish and selected fruits and vegetables) are eliminated. After 4 weeks, the subjects will be blindly assigned to placebo versus nutritional supplement groups from Weeks 9-16. Nutritional supplements will include a multi-vitamin, multi-mineral formulation with essential fatty acids and probiotics. At Week 21, restricted foods will be reintroduced into the diets.

Inclusion criteria:

(1) Children (aged 7 to 9 years) who meet the criteria for attention deficit hyperactivity disorder (ADHD) as defined by the DSM-IV
(2) Willingness to participate in research study requiring dietary changes, twice a day nutritional supplement or placebo tablets
(3) Willingness to come to Georgetown University Medical Center for periodic visits during the course of the 24 week study

(1) History of severe generalized allergic reaction (e.g., generalized urticaria, angioedema, bronchospasm or anaphylaxis) to food or inhalant allergens
(2) Any comorbid chronic medical illness (e.g., diabetes mellitus, renal or liver disease, HIV infection, seizure disorder, autism)
(3) Hyperkinesis which is attributable to a known medical or psychological cause (e.g., subclinical seizure disorder, lead encephalopathy, anxiety or other psychiatric diagnosis)
(4) Any gastroesophageal problems which would interfere with swallowing ability
(5) Screening laboratory results outside of the normal limits for age group

For more information at the Georgetown University Washington D.C. site, please contact Dawn Wallerstedt, FNP at 202-687-8227 and at the UCSF San Francisco site, Dr. Emily Toch at 415-476-7585.

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The International Center for Interdisciplinary Studies of Immunology
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