An interventional study of Ketogenic diet in Drug Resistant Epilepsy, Ketogenic Diet and Feasibility, sponsored by Number 2 Children's Hospital, Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Number 2 Children's Hospital, Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
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.
270 studies on the registry are indexed under Drug Resistant Epilepsy; 100 are open to participants now.
This study's enrollment of 45 is above the median of 30 across 213 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Number 2 Children's Hospital, Ho Chi Minh City is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- clinical or laboratory features suggesting an underlying disease contra-indication the use of a 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 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 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
The feasibility of the ketogenic diet
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
Time frame: 12 months
The tolerability of the ketogenic diet at 12 months
Number of participants without ketogenic diet's side effect at 12 months
Time frame: 12 months
The efficacy of the ketogenic diet at 12 months
The number of participants had a 50% seizure decrease at 12 months
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Oct 2021, 28 months.
Of 94 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 75. This study's 28 months is below that.
Counting every sponsor, half of 106 studies reached it within 34 months; a quarter within 21 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Number 2 Children's Hospital, Ho Chi Minh City