Refractory EpilepsyPhase 3NCT01645072
Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy
A Phase 3 study testing Low glycemic index diet in people with Refractory Epilepsy, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Low glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Oct 2012
- Phase
- Phase 3
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 -15 years with refractory epilepsy*
- Willing to come for regular follow up
- No motivational or psychosocial issues in the family which would preclude compliance with the diet * Refractory epilepsy is defined as seizures persisting daily or more than 7 per week despite the adequate trials of at least three tolerated and appropriately chosen anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin will be considered as eligible for inclusion.
Who cannot join
- Surgically remediable cause for refractory epilepsy
- Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
- Previously received ketogenic diet or modified Atkins diet
- Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Lakshminarayanan K, MD, 919013232893, dr_kln@yahoo.co.in
Sheffali Gulati, +91-11-26594679, sheffaligulati@gmail.com
About this study
Official title: Efficacy of Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy - A Randomized Controlled Trial
Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy surgery warrants the need for alternative treatments. Ketogenic diet is effective for refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction in seizures from the baseline and 15-20% become seizure free) and has gained widespread acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting seizure reduction comparable to that of patients on ketogenic diet. There have been no randomized controlled trials assessing the efficacy of the low glycemic index diet in refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with drug refractory epilepsy.
Read the detailed description
Each patient will undergo detailed clinical evaluation according to a structured proforma. Seizure type, frequency, age at onset, perinatal details, family history, developmental status and treatment history will be recorded. Corticosteroids or ACTH (if patient is already on) would be tapered off 2 weeks before starting LGIT. All co-medications will be changed to carbohydrate free preparations, wherever available only in the intervention group.
Eligible patients will be randomized in to two groups: the intervention and the control arm. Both groups will undergo a baseline four week observation period, during which parents will be asked to maintain a daily seizure log; recording seizure type, duration and frequency. In the intervention arm, the children will be started on low glycemic index diet after this 4-week baseline period. The control group will receive their usual diet without any alteration. No changes will be made to the patients' antiepileptic medication during the 4-week baseline or the 3-month study periods in both the intervention and control groups, unless medically indicated; e.g. drug side effects, or status epilepticus; in which case appropriate changes will be made to their medications and same will be documented. The drop out from the intervention group will be documented along with the reason for the same. At the end of the 3 month study period patient in the intervention arm will be continued with the LGIT but that will not come under the purview of this study. At the end of three months study period, patients in the control arm will be offered the option of low glycemic index diet treatment.
Low glycemic index diet administration
- Three day food intake by recall method will be documented
- The calorie requirement would be calculated as per the recommended daily allowance (RDA) for the ideal weight for that age
- Diet regime will be explained to the parents
- Patients (wherever applicable) and their parents will be given diet counseling
- LGIT will be started on out patient basis.
- Medium and high-GI carbohydrates (GI >55) will be eliminated from the diet and only food items with low glycemic index (GI <55) will be allowed. Parent will be given a list of low glycemic index food items33. They will also be given a list of food items (medium and high glycemic index) which should be avoided. (Appendix)
- Total carbohydrates intake will be restricted to 10% of caloric intake/ day (maximum 40-60 g/day).
- Carbohydrate values of various food items will be explained in detail, and carbohydrate exchange lists will be provided to the parent. Three to four 15 gram carbohydrate exchanges will be allowed in a day. (Appendix)
- Fats (e.g. cream, butter, oils and ghee) can be taken by the patient without any restriction.
- Proteins intake will be allowed up to 30% of the total caloric intake per day (cheese, fish, eggs, chicken and soya products).
- Sample menu will be discussed with the parent.
- Clear carbohydrate free fluids will not be restricted.
Follow up Children will be reviewed as outpatients at 1, 2 and 3 months. A three day dietary intake chart will be reviewed at each visit to compute calorie and carbohydrate intake, and to evaluate and reinforce compliance with the prescribed diet. Weight will be checked at each visit.
- Conditions
- Refractory Epilepsy
- Being tested
- Low glycemic index diet, Control group
- Keywords
- Drug refractory epilepsy, Dietary therapy, ketogenic diet, childhood epilepsy
- 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.
Low glycemic index dietOther
Diet modification in addition to ongoing anti epileptic drug treatment. Medium and high-GI carbohydrates (GI >55) will be eliminated from the diet and only food items with low glycemic index (GI <55) will be allowed. Parent will be given a list of low glycemic index food items. They will also be given a list of food items (medium and high glycemic index) which should be avoided.
Control groupOther
The ongoing anti epileptic drug treatment will be continued without change.
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index diet | Experimental | The patients will be started on low glycemic index diet. Receives: Other: Low glycemic index diet |
| Control group | Other | Standard care. The control group will receive their usual diet without any alteration. No changes will be made to the patients' antiepileptic medication during the 4-week baseline or the 3-month study periods in both the intervention and control groups, unless medically indicated; e.g. drug side effects, or status epilepticus; in which case appropriate changes will be made to their medications and same will be documented. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure control
Proportion of patients who achieve > 50% seizure reduction (Seizure frequency measured as average seizure per week in the preceding 4 week period) from the baseline
Measured: 3 months
Secondary outcomes (2)
Adverse events
Proportion and nature of adverse events in both the groups
Measured: 3 months
Withdrawal rate
Proportion of patients withdrawing from the LGIT plus antiepileptic drug treatment group during the study period and reasons for withdrawal.
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 posted20 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- Sheffali Gulati, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645072
- Sponsor's protocol ID
- AIIMS
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01645072
- Acronym / sponsor ID
- AIIMS
- Conditions
- Refractory Epilepsy
- Keywords
- Drug refractory epilepsy, Dietary therapy, ketogenic diet, childhood epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 20 Jul 2012 (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.
Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy surgery warrants the need for alternative treatments. Ketogenic diet is effective for refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction in seizures from the baseline and 15-20% become seizure free) and has gained widespread acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting seizure reduction comparable to that of patients on ketogenic diet. There have been no randomized controlled trials assessing the efficacy of the low glycemic index diet in refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with drug refractory epilepsy.
Detailed description
Each patient will undergo detailed clinical evaluation according to a structured proforma. Seizure type, frequency, age at onset, perinatal details, family history, developmental status and treatment history will be recorded. Corticosteroids or ACTH (if patient is already on) would be tapered off 2 weeks before starting LGIT. All co-medications will be changed to carbohydrate free preparations, wherever available only in the intervention group.
Eligible patients will be randomized in to two groups: the intervention and the control arm. Both groups will undergo a baseline four week observation period, during which parents will be asked to maintain a daily seizure log; recording seizure type, duration and frequency. In the intervention arm, the children will be started on low glycemic index diet after this 4-week baseline period. The control group will receive their usual diet without any alteration. No changes will be made to the patients' antiepileptic medication during the 4-week baseline or the 3-month study periods in both the intervention and control groups, unless medically indicated; e.g. drug side effects, or status epilepticus; in which case appropriate changes will be made to their medications and same will be documented. The drop out from the intervention group will be documented along with the reason for the same. At the end of the 3 month study period patient in the intervention arm will be continued with the LGIT but that will not come under the purview of this study. At the end of three months study period, patients in the control arm will be offered the option of low glycemic index diet treatment.
Low glycemic index diet administration
- Three day food intake by recall method will be documented
- The calorie requirement would be calculated as per the recommended daily allowance (RDA) for the ideal weight for that age
- Diet regime will be explained to the parents
- Patients (wherever applicable) and their parents will be given diet counseling
- LGIT will be started on out patient basis.
- Medium and high-GI carbohydrates (GI >55) will be eliminated from the diet and only food items with low glycemic index (GI <55) will be allowed. Parent will be given a list of low glycemic index food items33. They will also be given a list of food items (medium and high glycemic index) which should be avoided. (Appendix)
- Total carbohydrates intake will be restricted to 10% of caloric intake/ day (maximum 40-60 g/day).
- Carbohydrate values of various food items will be explained in detail, and carbohydrate exchange lists will be provided to the parent. Three to four 15 gram carbohydrate exchanges will be allowed in a day. (Appendix)
- Fats (e.g. cream, butter, oils and ghee) can be taken by the patient without any restriction.
- Proteins intake will be allowed up to 30% of the total caloric intake per day (cheese, fish, eggs, chicken and soya products).
- Sample menu will be discussed with the parent.
- Clear carbohydrate free fluids will not be restricted.
Follow up Children will be reviewed as outpatients at 1, 2 and 3 months. A three day dietary intake chart will be reviewed at each visit to compute calorie and carbohydrate intake, and to evaluate and reinforce compliance with the prescribed diet. Weight will be checked at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index diet | Experimental | Other: Low glycemic index dietThe patients will be started on low glycemic index diet. |
| Control group | Other | Other: Control groupStandard care. The control group will receive their usual diet without any alteration. No changes will be made to the patients' antiepileptic medication during the 4-week baseline or the 3-month study periods in both the intervention and control groups, unless medically indicated; e.g. drug side effects, or status epilepticus; in which case appropriate changes will be made to their medications and same will be documented. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 -15 years with refractory epilepsy*
- Willing to come for regular follow up
- No motivational or psychosocial issues in the family which would preclude compliance with the diet * Refractory epilepsy is defined as seizures persisting daily or more than 7 per week despite the adequate trials of at least three tolerated and appropriately chosen anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin will be considered as eligible for inclusion.
Key exclusion criteria (4 listed)
- Surgically remediable cause for refractory epilepsy
- Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
- Previously received ketogenic diet or modified Atkins diet
- Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness
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 |
|---|---|---|
| Low glycemic index dietDiet modification in addition to ongoing anti epileptic drug treatment. Medium and high-GI carbohydrates (GI >55) will be eliminated from the diet and only food items with low glycemic index (GI <55) will be allowed. Parent will be given a list of low glycemic index food items. They will also be given a list of food items (medium and high glycemic index) which should be avoided. | Other | Low glycemic index diet |
| Control groupThe ongoing anti epileptic drug treatment will be continued without change. | Other | Control group |
Primary outcome
Seizure control
Time frame: 3 months
Proportion of patients who achieve > 50% seizure reduction (Seizure frequency measured as average seizure per week in the preceding 4 week period) from the baseline
2 secondary outcomes
Adverse events
Time frame: 3 months
Withdrawal rate
Time frame: 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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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.
Sheffali Gulati, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low glycemic index diet in people with Refractory Epilepsy, run by All India Institute of Medical Sciences at 1 site in India.
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 4 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 20 Jul 2012. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sheffali Gulati, MD (+91-11-26594679, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure control (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 20 Jul 2012.