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Completed

NCT Number: NCT05697887

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.

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Children Efficacy Epilepsy Feasibility Ketogenic Diet Nervous System Diseases Tolerability

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

N02 Children's Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet

Dietary Supplement

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

Primary outcomes

  1. The feasibility of the ketogenic diet

    Time frame: 12 months

    Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication

  2. The tolerability of the ketogenic diet at 12 months

    Time frame: 12 months

    Number of participants without ketogenic diet's side effect at 12 months

  3. The efficacy of the ketogenic diet at 12 months

    Time frame: 12 months

    The number of participants had a 50% seizure decrease at 12 months

Sponsors and collaborators

Lead sponsor

Number 2 Children's Hospital, Ho Chi Minh City

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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