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Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy (SMAD)

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ClinicalTrials.gov Identifier: NCT01899898
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Refractory Epilepsy Other: Simplified Modified Atkins Diet Drug: Antiepileptic drugs alone Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
Study Start Date : September 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Simplified Modified Atkins Diet Other: Simplified Modified Atkins Diet

Modified 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.

Active Comparator: Antiepileptic drugs alone Drug: Antiepileptic drugs alone
The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Tolerability and the adverse effects of the simplified modified Atkins diet [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Proportion of patients withdrawing from the simplified modified Atkins diet plus antiepileptic drug treatment group during the study period [ Time Frame: 3 months ]


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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 2 - 14 years.
  2. 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.

Exclusion Criteria:

  1. 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.

  2. 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.

  3. Motivational or psychosocial issues in the family which would preclude compliance
  4. Systemic illness- chronic hepatic, renal or pulmonary disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899898


Locations
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India
Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: Satinder Aneja, MD Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

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Responsible Party: Satinder Aneja, Director Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01899898     History of Changes
Other Study ID Numbers: SMAD
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Keywords provided by Satinder Aneja, Lady Hardinge Medical College:
Refractory epilepsy
Dietary therapy
Non-Pharmacological therapy
Simplified Modified Atkins Diet

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants