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Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).

A

Ain Shams University

Status

Not yet enrolling

Conditions

Attention Deficit Disorder

Treatments

Dietary Supplement: oligoantigenic diet
Other: Food regimen without food restrictions.

Study type

Interventional

Funder types

Other

Identifiers

NCT06491836
FMASU MS157/2024

Details and patient eligibility

About

Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.

Enrollment

50 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.

Exclusion criteria

  • Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
  • Intelligence quotient (IQ) of patients less than 80%.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Arm 1: Patients who will follow food regimen without any food restriction.
Active Comparator group
Treatment:
Other: Food regimen without food restrictions.
Arm 2: Patients who will follow food regimen based on oligoantigenic diet.
Experimental group
Treatment:
Dietary Supplement: oligoantigenic diet

Trial contacts and locations

0

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Central trial contact

Haya E Ibrahim, MD

Data sourced from clinicaltrials.gov

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