EpilepsyNCT02100501
Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy
An observational study of Epilepsy, run by Yonsei University at 1 site in South Korea.
Trial summary
The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Epilepsy
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Mar 2013
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: the patients were recriuted from the Pediatric Neurology Outpatient Clinic, Severance Children's Hospital. This study conducted on 104 (Ketogenic diet - 51, Atkin's diet - 53) patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.
Who may be able to join
- Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.
Who cannot join
- Patients heve been tried KD or MAD before.
- Patients with renal stones, hyperlipidemia, cardiologic problems.
- Other conditions not adjust for dietary therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.
- Conditions
- Epilepsy
- Keywords
- Seizure control through dietary therapy in pediatric intractable epilepsy patients.
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atkins diet group | pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 53. enrolled patients are assigned to randomly in one of KD group or Atkins group. | |
| Ketogenic diet group | pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 51. enrolled patients are assigned to randomly in one of KD group or Atkins group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure outcome 3months after dietary therapy.
1 and 3 month after dietary therapy, enrolled patients were required to visit outpatient clinic to record their seizure frequency. we compile statistics and compare seizure frequencies before and after dietary treatment in each KD group and MAD group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoon-Chul Kang, MD, Principal investigator, Severance Children's Hospital, Yonsei University college of medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100501
- Sponsor's protocol ID
- 4-2011-0003
- Status last verified
- Feb 2015
- First submitted
- 26 Mar 2014
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JA, Yoon JR, Lee EJ, Lee JS, Kim JT, Kim HD, Kang HC. Efficacy of the classic ketogenic and the modified Atkins diets in refractory childhood epilepsy. Epilepsia. 2016 Jan;57(1):51-8. doi: 10.1111/epi.13256. Epub 2015 Dec 10.
PubMed 26662710
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy
- ClinicalTrials.gov ID
- NCT02100501
- Acronym / sponsor ID
- 4-2011-0003
- Conditions
- Epilepsy
- Keywords
- Seizure control through dietary therapy in pediatric intractable epilepsy patients.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Apr 2014 (estimated)
- 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.
The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atkins diet group | – | –pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 53. enrolled patients are assigned to randomly in one of KD group or Atkins group. |
| Ketogenic diet group | – | –pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 51. enrolled patients are assigned to randomly in one of KD group or Atkins group. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- the patients were recriuted from the Pediatric Neurology Outpatient Clinic, Severance Children's Hospital. This study conducted on 104 (Ketogenic diet - 51, Atkin's diet - 53) patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.
Key inclusion criteria (1 listed)
- Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.
Key exclusion criteria (3 listed)
- Patients heve been tried KD or MAD before.
- Patients with renal stones, hyperlipidemia, cardiologic problems.
- Other conditions not adjust for dietary therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
seizure outcome 3months after dietary therapy.
Time frame: 3 months
1 and 3 month after dietary therapy, enrolled patients were required to visit outpatient clinic to record their seizure frequency. we compile statistics and compare seizure frequencies before and after dietary treatment in each KD group and MAD group.
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 25 Feb 2015.
- Derived from this study: PubMed 26662710Kim JA, Yoon JR, Lee EJ, Lee JS, Kim JT, Kim HD, Kang HC. Efficacy of the classic ketogenic and the modified Atkins diets in refractory childhood epilepsy. Epilepsia. 2016 Jan;57(1):51-8. doi: 10.1111/epi.13256. Epub 2015 Dec 10.
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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.
Hoon-Chul Kang, MD principal investigator
Severance Children's Hospital, Yonsei University college of medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 3 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 25 Feb 2015. 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 South Korea. 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?
seizure outcome 3months after dietary therapy. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100501, which also lists 1 linked publication.
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 25 Feb 2015.