Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet

November 28, 2025 updated by: Mahmoud Saber Elsayed, Sohag University

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

  1. Control of seizures(frequency , duration and numbers of hospital admissions) .
  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, height will be combined to report BMI in kg/m^2).

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • - Patients with contraindicated metabolic/genetic conditions.
  • Non-compliance with KD .

Patients on alternative dietary therapies (e.g., low glycemic diet)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
to detect clinical predictors of seizures control ( frequency of attack and duration) in patients with drug resistant epilepsy using MAD.
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-med-25-9-IMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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