- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01880333
Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy
January 12, 2019 updated by: Satinder Aneja, Lady Hardinge Medical College
Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet.
This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids.
Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians.
However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children.
This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India, 110001
- Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 months to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 9 months to 3 years.
- Seizures persisting at least three per week for > 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.
Exclusion Criteria:
- Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
- Severe acute malnutrition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Children on Modified Atkin Diet
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Eligible children will be started on Modified Atkins diet with help of trained dietician.
Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail.
Fats (e.g.
cream, butter, oils, and ghee) will be encouraged.
Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted.
Calcium and multivitamin supplementation will be done.
Syrups will be restricted.
Clear carbohydrates free fluids- will not be restricted.
Medications will be changed to carbohydrate free preparations, wherever available.
Diary of events will be recorded including seizure frequency and any adverse or positive effect.
Urine ketones chart will be maintained.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of children with > 50% seizure reduction at 3 months
Time Frame: After 3 months of diet initiation
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After 3 months of diet initiation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of adverse effects of the modified Atkins diet.
Time Frame: 3 months
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3 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of children with seizure freedom at 3 months
Time Frame: 3 months
|
3 months
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Percentage of children discontinuing diet before 3 months as per parenteral reports
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Satinder Aneja, MD, Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 14, 2013
First Posted (Estimate)
June 18, 2013
Study Record Updates
Last Update Posted (Actual)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 12, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MADRE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory Epilepsy
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NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
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Madeline FieldsRecruitingDrug Resistant Epilepsy | Refractory Epilepsy | Medically Refractory EpilepsyUnited States
-
University of Colorado, DenverColorado Department of Public Health and EnvironmentUnknownEpilepsy, Unspecified, Refractory (Medically)United States
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University Hospital, MontpellierRecruitingRefractory EpilepsyFrance
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Boston Children's HospitalRecruitingEpilepsy | Epilepsy IntractableUnited States
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Seattle Children's HospitalAadi Bioscience, Inc.CompletedEpilepsy IntractableUnited States
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Cliniques universitaires Saint-Luc- Université...RecruitingRefractory EpilepsyBelgium
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University Hospital, GhentUniversity GhentRecruiting
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University Hospital, GhentResearch Foundation FlandersCompletedEpilepsyBelgium, United States
-
Wake Forest University Health SciencesTerminatedEpilepsy | Refractory EpilepsyUnited States
Clinical Trials on Modified Atkin Diet
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Seattle Children's HospitalCompleted
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University College CorkCompleted
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Vanderbilt UniversityCompletedCircadian Rhythms | MetabolismUnited States
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Azienda Ospedaliero, Universitaria PisanaUnknown
-
Yonsei UniversityCompletedKetogen-based Therapeutic Diet | Pancreaticobiliary CancerKorea, Republic of
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Hadassah Medical OrganizationCompletedObese Type 2 Diabetic Patients
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University of Wisconsin, MadisonNational Institutes of Health (NIH); Wisconsin Institute for Clinical and Translational...SuspendedEpilepsy | SeizuresUnited States
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Johns Hopkins UniversityVascular Birthmarks FoundationCompletedEpilepsy | Sturge Weber SyndromeUnited States
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Johns Hopkins UniversityCompleted
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Loma Linda UniversityEnrolling by invitationTraumatic Brain InjuryUnited States