Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet

NCT07275125 | Not Yet Recruiting

• 1 other identifier: Soh-med-25-9-IMS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points:

1. 1.Control of seizures(frequency , duration and numbers of hospital admissions) .
2. 2.Quality of life by pediatric quality of life inventory v4.
3. 3.Cognitive function by stanford binet intelligence scale 5th edition.
4. 4.Growth parameters ( weight, height will be combined to report BMI in kg/m\^2).

Conditions

Drug Resistant Epilepsy

Outcome Measures

Primary Outcomes (1)

• 1-Control of seizures(frequency and duration of seizures) . 2-Quality of life by pediatric quality of life inventory v4. 3-Cognitive function by stanford binet intelligence scale 5th edition. 4-Growth parameters (weight and height by BMI in kg/m^2)

  6 month

Secondary Outcomes (1)

• to detect clinical predictors of seizures control ( frequency of attack and duration) in patients with drug resistant epilepsy using MAD.

  6 month

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include pediatric patients with drug-resistant epilepsy (DRE) attending the ketogenic diet clinic at the Pediatric Neurology Unit, Sohag University Hospital. Eligible participants are children aged 1-18 years who meet the International League Against Epilepsy (ILAE) definition of DRE and have been on a ketogenic dietary therapy, specifically the Modified Atkins Diet (MAD), for at least 6 months.

You may qualify if:

• Children aged 1-18 years.
• Diagnosed with drug-resistant epilepsy according to ILAE definition.\[2\]
• On KD for at least 6 months.

You may not qualify if:

• \- Patients with contraindicated metabolic/genetic conditions.
• Non-compliance with KD .
• Patients on alternative dietary therapies (e.g., low glycemic diet)

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Mahmoud Saber Elsayed

CONTACT

00201069770585; Mm.ss.elsayed277@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 10, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

EG (1)