Refractory EpilepsyPhase 2/3SMADNCT01899898
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
A Phase 2/3 study testing Simplified Modified Atkins Diet and Antiepileptic drugs alone in people with Refractory Epilepsy, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Simplified Modified Atkins Diet and Antiepileptic drugs alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2012to Nov 2015
- Phase
- Phase 2/3
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2 - 14 years.
- Seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and EEG findings.
Who cannot join
- Known or suspected inborn error of metabolism:
- Patients with 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 With or without 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.
- In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.
- Surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy.
- We will perform MRI brain, and short term video-EEG in all patients with focal seizures to look for surgically remediable causes.
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, renal or pulmonary disease
Trial locations and contacts
1 site in 1 country.
India1 site
Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible.
This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.
- Conditions
- Refractory Epilepsy
- Being tested
- Simplified Modified Atkins Diet, Antiepileptic drugs alone
- Keywords
- Refractory epilepsy, Dietary therapy, Non-Pharmacological therapy, Simplified Modified Atkins Diet
- 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.
Simplified Modified Atkins DietOther
Modified Atkins diet with the following modifications:
- Pictorial representation of various food items and exchange lists will be provided.
- Instead of weights, we will provide standardized measures
- We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures
- We will formulate recipes and diets based on locally available and culturally acceptable foods.
- We will develop a parent instruction manual.
- We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes.
- We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes.
Antiepileptic drugs aloneDrug
The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet
| Study group | Role | What they receive |
|---|---|---|
| Simplified Modified Atkins Diet | Experimental | Not described Receives: Other: Simplified Modified Atkins Diet |
| Antiepileptic drugs alone | Active comparator | Not described Receives: Drug: Antiepileptic drugs alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion patients who achieve > 50% seizure reduction from the baseline in the simplified modified Atkins diet plus anti-epileptic drug therapy group at 3 months in comparison to the anti-epileptic drug therapy alone group
Measured: 3 months
Secondary outcomes (1)
Tolerability and the adverse effects of the simplified modified Atkins diet
Tolerability of the diet and any adverse events will be evaluated by means of parental interview at each visit. Parents will be questioned for the following symptoms - vomiting, lethargy, poor appetite, refusal to feed and constipation in particular. Any other parental concerns will also be noted. The proportion of patients with each symptom in both the groups will be evaluated.
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 posted16 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2015
- Study completionNov 2015
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Satinder Aneja, Lady Hardinge Medical College
- Investigators
- Satinder Aneja, MD, Principal investigator, Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899898
- Sponsor's protocol ID
- SMAD
- Acronym
- SMAD
- Status last verified
- Jan 2019
- First submitted
- 14 Jun 2013
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.
PubMed 32588435
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT01899898
- Acronym / sponsor ID
- SMAD / SMAD
- Conditions
- Refractory Epilepsy
- Keywords
- Refractory epilepsy, Dietary therapy, Non-Pharmacological therapy, Simplified Modified Atkins Diet
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Jul 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.
One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible.
This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified Modified Atkins Diet | Experimental | Other: Simplified Modified Atkins Diet |
| Antiepileptic drugs alone | Active comparator | Drug: Antiepileptic drugs alone |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 2 - 14 years.
- Seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and EEG findings.
Key exclusion criteria (7 listed)
- Known or suspected inborn error of metabolism:
- Patients with 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 With or without 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.
- In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.
- Surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy.
- We will perform MRI brain, and short term video-EEG in all patients with focal seizures to look for surgically remediable causes.
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 |
|---|---|---|
| Simplified Modified Atkins DietModified Atkins diet with the following modifications: 1. Pictorial representation of various food items and exchange lists will be provided. 2. Instead of weights, we will provide standardized measures 3. We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures 4. We will formulate recipes and diets based on locally available and culturally acceptable foods. 5. We will develop a parent instruction manual. 6. We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes. 7. We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes. | Other | Simplified Modified Atkins Diet |
| Antiepileptic drugs aloneThe anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet | Drug | Antiepileptic drugs alone |
Primary outcome
The proportion patients who achieve > 50% seizure reduction from the baseline in the simplified modified Atkins diet plus anti-epileptic drug therapy group at 3 months in comparison to the anti-epileptic drug therapy alone group
Time frame: 3 months
1 secondary outcome
Tolerability and the adverse effects of the simplified modified Atkins diet
Time frame: 3 months
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 15 Jan 2019.
- Derived from this study: PubMed 32588435Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.
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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.
Satinder Aneja, MD principal investigator
Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Simplified Modified Atkins Diet and Antiepileptic drugs alone in people with Refractory Epilepsy, run by Lady Hardinge Medical College 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 2 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 combined 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.
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?
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?
The proportion patients who achieve > 50% seizure reduction from the baseline in the simplified modified Atkins diet plus anti-epileptic drug therapy group at 3 months in comparison to the anti-epileptic drug therapy alone group (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 NCT01899898, 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 15 Jan 2019.