N/A
N=29
Neuroimaging of Diet in ADHD: Phase I
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT01862484 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: ADHD Rating Scale IV — 18.0; 21.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restricted Diet (Dietary_supplement); Ruse Diet (Dietary_supplement)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD Rating Scale IV |
18.0; 21.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 9-12 years
- Meets criteria for Attention Deficit Hyperactivity Disorder
- Parent must agree to use Study Diet Manual
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01862484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.