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

NCT05697887 | Completed DMC

• 1 other identifier: CH2HCM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Resistant Epilepsy; Ketogenic Diet; Feasibility; Tolerability; Efficacy; Children

Keywords

drug resistant epilepsy; ketogenic diet

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

The feasibility of the ketogenic diet

EXPERIMENTAL

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 tolerability of the ketogenic diet

EXPERIMENTAL

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 efficacy of the ketogenic diet

EXPERIMENTAL

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

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

The feasibility of the ketogenic diet; the efficacy of the ketogenic diet; the tolerability of the ketogenic diet

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

N02 Children's Hospital

Ho Chi Minh City, Ho Chi Minh, 848, Vietnam

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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 responder when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 26, 2023
• Study Start: June 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)