Neuroimaging of Diet in ADHD: Phase I

NCT01862484 | Completed Results DMC

• 1 other identifier: R21MH09680
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Diet; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale IV

  The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.

  5 weeks

Study Arms (2)

Restricted Diet

EXPERIMENTAL

Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.

Dietary Supplement: Restricted Diet

Ruse Diet

SHAM COMPARATOR

Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.

Dietary Supplement: Ruse Diet

Interventions

Restricted Diet DIETARY_SUPPLEMENT

Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.

Restricted Diet

Ruse Diet DIETARY_SUPPLEMENT

Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet

Ruse Diet

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 9-12 years
• Meets criteria for Attention Deficit Hyperactivity Disorder
• Parent must agree to use Study Diet Manual

You may not qualify if:

• Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management
• Not currently on any pharmacological agent other than medication for ADHD

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Steven R. Pliszka MD
• Organization: The University of Texas Health Science Center at San Antonio

pliszka@uthscsa.edu

210-567-0136

Study Officials

• Stevn R Pliszka, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 24, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 13, 2015
• Results First Posted: March 13, 2015

Record last verified: 2015-03

Locations

US (1)