Refractory EpilepsyPhase 2NCT03031028
Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.
A Phase 2 study testing ketogenic diet in people with Refractory Epilepsy, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jul 2016to Mar 2017
- Phase
- Phase 2
- 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
Who may be able to join
- Ages 1-18 years,
- The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
- The parents are willing to include their child in the study after written and verbal information.
- Patients with all types of epilepsy can be included.
- The patient is submitted to our epilepsy center.
Who cannot join
- The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
- The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
- No history of hyperlipidemia
- No history of renal stones
- No previous treatment with ketogenic diet
- Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3- hydroxyacyl-CoA deficiency.
- The family is expected to have compliance problems with treatment and/or seizure registration
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Tehran university of medical science, school of nutritional science and dietetics
Tehran, Tehran Province
Maryam Mahmoudi, MD,PHD, 00989126182883, m-mahmoudi@sina.tums.ac.ir
Mona Kavoosi, MSc student
About this study
Official title: The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.
This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.
Read the detailed description
This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy.
30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.
- Conditions
- Refractory Epilepsy
- Being tested
- ketogenic diet
- Keywords
- refractory epilepsy,, ketogenic diet, classic ketogenic diet, seizure rate, efficacy, epilepsy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketogenic dietOther
Ketogenic Diet is a high fat, low carbohydrate diet.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet | Other | Ketogenic diet Receives: Other: ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure rate
The information will be obtained through seizure diary
Measured: 3 months
Secondary outcomes (7)
Height
Height of the participants will be assessed by stadiometer and Unit for height is cm.
Measured: Before and after 1 and 3 months on the classical KD.
Investigating side effects
Side effects will be obtained via parents' reports.
Measured: After 3 months on the classical KD
serum Triglyceride
serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Measured: Before and after 3 months on the classical KD
Weight
Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.
Measured: Before and after 1 and 3 months on the classical KD.
serum Cholesterol,
serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.
Measured: Before and after 3 months on the classical KD
serum LDL-Cholesterol
serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.
Measured: Before and after 3 months on the classical KD.
serum HDL-Cholesterol
serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL
Measured: Before and after 3 months on the classical KD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Mahmoudi, MD, PHD, Study director, Tehran university of medical science, school of Nutritional science and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031028
- Sponsor's protocol ID
- 94-03-161-30342
- Status last verified
- Sep 2016
- First submitted
- 31 Dec 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.
- ClinicalTrials.gov ID
- NCT03031028
- Acronym / sponsor ID
- 94-03-161-30342
- Conditions
- Refractory Epilepsy
- Keywords
- refractory epilepsy,, ketogenic diet, classic ketogenic diet, seizure rate, efficacy, epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Jan 2017 (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.
This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.
Detailed description
This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy.
30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet | Other | Other: ketogenic dietKetogenic diet |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 1-18 years,
- The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
- The parents are willing to include their child in the study after written and verbal information.
- Patients with all types of epilepsy can be included.
- The patient is submitted to our epilepsy center.
Key exclusion criteria (7 listed)
- The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
- The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
- No history of hyperlipidemia
- No history of renal stones
- No previous treatment with 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 dietKetogenic Diet is a high fat, low carbohydrate diet. | Other | ketogenic diet |
Primary outcome
seizure rate
Time frame: 3 months
The information will be obtained through seizure diary
7 secondary outcomes
Height
Time frame: Before and after 1 and 3 months on the classical KD.
Investigating side effects
Time frame: After 3 months on the classical KD
serum Triglyceride
Time frame: Before and after 3 months on the classical KD
Weight
Time frame: Before and after 1 and 3 months on the classical KD.
serum Cholesterol,
Time frame: Before and after 3 months on the classical KD
serum LDL-Cholesterol
Time frame: Before and after 3 months on the classical KD.
serum HDL-Cholesterol
Time frame: Before and after 3 months on the classical KD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Maryam Mahmoudi, MD, PHD study director
Tehran university of medical science, school of Nutritional science and Dietetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketogenic diet in people with Refractory Epilepsy, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Mahmoudi, MD, PHD (00989126182883, m-mahmoudi@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure rate (time frame: 3 months). 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 25 Jan 2017.