EpilepsyPhase 2NCT01983163
Dietary Therapy in Children With Refractory Epilepsy
A Phase 2 study testing Ketogenic diet (2.5 to 4:1) and Modified Atkin's diet in people with Epilepsy, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Ketogenic diet (2.5 to 4:1) and Modified Atkin's diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2013to Jul 2014
- 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
- Children aged 1-18 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
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
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months
Read the detailed description
Primary objective:
To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line.
Secondary objective:
Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups
- Conditions
- Epilepsy
- Being tested
- Ketogenic diet (2.5 to 4:1), Modified Atkin's diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet (2.5 to 4:1)Other
Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
Modified Atkin's dietOther
1:1 fixed ketogenic ratio Modified atkins diet will be given
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet | Active comparator | ketogenic diet (2.5 to 4:1) Receives: Other: Ketogenic diet (2.5 to 4:1) |
| Modifid Atkin's diet | Active comparator | Modified Atkin's Diet Receives: Other: Modified Atkin's diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line
To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT01983163
- Sponsor's protocol ID
- 9968480606
- Status last verified
- Dec 2015
- First submitted
- 4 Nov 2013
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01983163
- Acronym / sponsor ID
- 9968480606
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Nov 2013 (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.
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months
Detailed description
Primary objective:
To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line.
Secondary objective:
Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet | Active comparator | Other: Ketogenic diet (2.5 to 4:1)ketogenic diet (2.5 to 4:1) |
| Modifid Atkin's diet | Active comparator | Other: Modified Atkin's dietModified Atkin's Diet |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 1-18 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
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 |
|---|---|---|
| Ketogenic diet (2.5 to 4:1)Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given | Other | ketogenic diet |
| Modified Atkin's diet1:1 fixed ketogenic ratio Modified atkins diet will be given | Other | Modifid Atkin's diet |
Primary outcome
Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line
Time frame: Baseline and 6 months
To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents
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 1 Jan 2016.
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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 2 study testing Ketogenic diet (2.5 to 4:1) and Modified Atkin's diet in people with 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: finished, as of the sponsor's last update on 1 Jan 2016. 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 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?
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?
Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line (time frame: Baseline and 6 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 1 Jan 2016.