Skip to content

Long term effectiveness and cost-effectiveness of an elimination diet trajectory compared to care as usual in the treatment of Attention Deficit/ Hyperactivity Disorder in children aged 5 to 12 year

Long term effectiveness and cost-effectiveness of an elimination diet trajectory compared to care as usual in the treatment of Attention Deficit/ Hyperactivity Disorder in children aged 5 to 12 year - TRACE: Treatment of ADHD with Care as usual versus an Elimination diet

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41838
Enrollment
301
Registered
2015-01-22
Start date
2015-10-06
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD attention-deficit/hyperactivity disorder

Interventions

The ED trajectory consists of a 5-week elimination phase, in which children consume a standardized diet, and a 12-18 months reintroduction phase to find those products triggering ADHD symptoms. Non-

Sponsors

Psychiatrie
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: • clinical ADHD diagnosis according to the DSM-5 (any subtype) • ADHD treatment abstinence in past 2 months • 5-12 years old • ADHD Rating Scale (ARS) score higher than 1.5 SD above the mean • confirmed research diagnosis by a structured psychiatric interview with the parents (K-SADS) [26]. • comorbidities are allowed, except for eating disorders

Exclusion criteria

Exclusion criteria: • children with current treatment for ADHD, or in the past two months (either receiving medication or behavioral therapy or a diet), • use of any other psychotropic medication, elimination diets, behavioral therapies • children and/or parents with inadequate mastery of the Dutch language • diabetes

Design outcomes

Primary

MeasureTime frame
Primary outcome: % children showing excellent response (>30% symptom reduction) based on blind assessment.

Secondary

MeasureTime frame
ADHD and comorbid behavior rated by parents and teachers, objective cognitive measures and motor activity, school functioning, quality of life, health status, adequacy of final diet assessed by a dietician and cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)