Drug Resistant EpilepsyNCT05697887
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
A study testing Ketogenic diet in people with Drug Resistant Epilepsy and Ketogenic Diet, run by Number 2 Children's Hospital, Ho Chi Minh City at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Drug Resistant Epilepsy, Ketogenic Diet, Feasibility
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Drug Resistant Epilepsy, Ketogenic Diet, Feasibility, Tolerability, Efficacy, Children
- Being tested
- Ketogenic diet
- Keywords
- drug resistant epilepsy, ketogenic diet
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Dietary Supplement: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of the ketogenic diet
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
Measured: 12 months
The tolerability of the ketogenic diet at 12 months
Number of participants without ketogenic diet's side effect at 12 months
Measured: 12 months
The efficacy of the ketogenic diet at 12 months
The number of participants had a 50% seizure decrease at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jun 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model 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 responder when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Number 2 Children's Hospital, Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuy-Minh-Thu NGUYEN, Number 2 Children's Hospital, Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697887
- Sponsor's protocol ID
- CH2HCM
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
- ClinicalTrials.gov ID
- NCT05697887
- Acronym / sponsor ID
- CH2HCM
- Conditions
- Drug Resistant Epilepsy, Ketogenic Diet, Feasibility, Tolerability, Efficacy, Children
- Keywords
- drug resistant epilepsy, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Number 2 Children's Hospital, Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model 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 responder when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.
| Arm | Type | Receives |
|---|---|---|
| The feasibility of the ketogenic diet | Experimental | Dietary Supplement: Ketogenic dietThe 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 |
| the tolerability of the ketogenic diet | Experimental | Dietary Supplement: Ketogenic dietThe 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 |
| the efficacy of the ketogenic diet | Experimental | Dietary Supplement: Ketogenic dietThe 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. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietThe ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy | Dietary supplement | The feasibility of the ketogenic diet, the efficacy of the ketogenic diet, the tolerability of the ketogenic diet |
Primary outcome
The feasibility of the ketogenic diet
Time frame: 12 months
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Drug Resistant Epilepsy and Ketogenic Diet, run by Number 2 Children's Hospital, Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of the ketogenic diet (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.