Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam

According to the World Health Organization, more than 50 million people have epilepsy. Among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment. The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy. Although it has been studied by few studies in Asia, no such studies have been conducted in Vietnam. The purpose of this study was to verify the feasibility, tolerability, and efficacy of the KD in children with refractory epilepsies followed at a pediatric center in South Vietnam.

Study Overview

• Status: Completed
• Conditions: Feasibility; Children; Efficacy; Drug Resistant Epilepsy; Tolerability; Ketogenic Diet
• Intervention / Treatment: Dietary supplement: Ketogenic diet

Detailed Description

Children with drug-resistant epilepsy followed at Children's Hospital No.2, Viet Nam treated by KD were included in a prospective study from June 2019 to October 2021. Side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9, and 12 months of KD. Patients were considered as responders when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh
    • Ho Chi Minh city, Ho Chi Minh, Vietnam, 848
      • N02 Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age from 1 to 10 years at the time of enrolment,
• drug-resistant epilepsy according to the 2010 ILAE criteria,
• an indication for a ketogenic diet trial according to the 2018 ILAE recommendations

Exclusion Criteria:

- clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The feasibility of the ketogenic diet; The purpose of this study was to verify the feasibility of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered feasible if he (or she) did not have the contra-indication for the ketogenic diet	Dietary supplement: Ketogenic diet; The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy
Experimental: the tolerability of the ketogenic diet; The purpose of this study was to verify the tolerability of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered tolerant if he (or she) did not have any side effects caused by the ketogenic diet	Dietary supplement: Ketogenic diet; The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy
Experimental: the efficacy of the ketogenic diet; The purpose of this study was to verify the efficacy of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. Patients were considered responders when a 50% seizure frequency was reached.	Dietary supplement: Ketogenic diet; The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of the ketogenic diet	Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication	12 months
The tolerability of the ketogenic diet at 12 months	Number of participants without ketogenic diet's side effect at 12 months	12 months
The efficacy of the ketogenic diet at 12 months	The number of participants had a 50% seizure decrease at 12 months	12 months

Collaborators and Investigators

• Sponsor: Number 2 Children's Hospital, Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ketogenic diet; drug resistant epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: CH2HCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No