Children Clinical Trial
Official title:
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
NCT number | NCT05697887 |
Other study ID # | CH2HCM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | October 31, 2021 |
Verified date | January 2023 |
Source | Number 2 Children's Hospital, Ho Chi Minh City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | N02 Children's Hospital | Ho Chi Minh city | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
Number 2 Children's Hospital, Ho Chi Minh City |
Vietnam,
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 |
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