Trial Outcomes & Findings for Neuroimaging of Diet in ADHD: Phase I (NCT NCT01862484)

Last Updated: 2015-03-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

5 weeks

Results posted on

2015-03-13

Participant Flow

Recruited through advertisement in magazines and flyers posted in child psychiatry clinics

40 children were enrolled, a total of 29 were randomized. Of the remaining 11, 8 were screen failures, 3 withdrew from the study prior to randomization.

Participant milestones

Participant milestones
Measure	Restricted Diet Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Ruse Diet Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Overall Study STARTED	15	14
Overall Study COMPLETED	13	6
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Restricted Diet Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Ruse Diet Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Overall Study Lack of Efficacy	1	1
Overall Study Lost to Follow-up	1	2
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Neuroimaging of Diet in ADHD: Phase I

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restricted Diet n=15 Participants Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Ruse Diet n=14 Participants Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 1.73 • n=5 Participants	10.83 years STANDARD_DEVIATION 1.25 • n=7 Participants	10.82 years STANDARD_DEVIATION 1.49 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Population: Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.

Outcome measures

Outcome measures
Measure	Restricted Diet n=15 Participants Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Ruse Diet n=14 Participants Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
ADHD Rating Scale IV	18.0 units on a scale Standard Deviation 10.9	21.3 units on a scale Standard Deviation 11.75

Adverse Events

Restricted Diet

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ruse Diet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Restricted Diet n=15 participants at risk Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Ruse Diet n=14 participants at risk Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Number of events 2 • 18 months	0.00% 0/14 • 18 months
Gastrointestinal disorders Acid Reflux	6.7% 1/15 • Number of events 1 • 18 months	0.00% 0/14 • 18 months
Infections and infestations Streptococcus Throat Infection	6.7% 1/15 • Number of events 1 • 18 months	0.00% 0/14 • 18 months
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 18 months	0.00% 0/14 • 18 months
General disorders Headache	0.00% 0/15 • 18 months	7.1% 1/14 • Number of events 1 • 18 months

Additional Information

Steven R. Pliszka MD

The University of Texas Health Science Center at San Antonio

Phone: 210-567-0136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place