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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697887
• Other study ID #: CH2HCM
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2023
• Source: Number 2 Children's Hospital, Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Vietnam	N02 Children's Hospital	Ho Chi Minh city	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Number 2 Children's Hospital, Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

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