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

NCT ID: NCT06491836

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-11-15

Brief Summary

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.

Conditions

Attention Deficit Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1: Patients who will follow food regimen without any food restriction.

Group Type: ACTIVE_COMPARATOR

Food regimen without food restrictions.

Intervention Type: OTHER

Food regimen that will cover recommended daily allowance (RDA) for macronutrients and micronutrients according patients' ages without any food restriction

Arm 2: Patients who will follow food regimen based on oligoantigenic diet.

Group Type: EXPERIMENTAL

oligoantigenic diet

Intervention Type: DIETARY_SUPPLEMENT

Oligoantigenic diet that will cover recommended daily allowance (RDA) of macronutrients and micronutrients according patients' ages according to our available sources of food in our culture and the diet consists typically of meat (e.g. chicken and lamb), carbohydrate sources (e.g., potatoes and rice), fruits (e.g., bananas, pears and apples), vegetables (e.g., cucumbers, carrot, lettuce, cauliflower, turnips, cabbage and broccoli)

Interventions

oligoantigenic diet

Oligoantigenic diet that will cover recommended daily allowance (RDA) of macronutrients and micronutrients according patients' ages according to our available sources of food in our culture and the diet consists typically of meat (e.g. chicken and lamb), carbohydrate sources (e.g., potatoes and rice), fruits (e.g., bananas, pears and apples), vegetables (e.g., cucumbers, carrot, lettuce, cauliflower, turnips, cabbage and broccoli)

Intervention Type: DIETARY_SUPPLEMENT

Food regimen without food restrictions.

Food regimen that will cover recommended daily allowance (RDA) for macronutrients and micronutrients according patients' ages without any food restriction

Intervention Type: OTHER

Eligibility Criteria

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%.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Haya Essam Ibrahim

lecturer of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, Abbassia, Egypt

Countries

Egypt

Other Identifiers

FMASU MS157/2024

Identifier Type: -

Identifier Source: org_study_id