This trial is active, not recruiting.

Condition refractory epilepsy
Treatments simplified modified atkins diet, antiepileptic drugs alone
Phase phase 2/phase 3
Sponsor Lady Hardinge Medical College
Start date April 2013
End date April 2016
Trial size 70 participants
Trial identifier NCT01899898, SMAD


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
simplified modified atkins diet
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.
(Active Comparator)
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 Outcomes

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 Outcomes

Tolerability and the adverse effects of the simplified modified Atkins diet
time frame: 3 months

Eligibility Criteria

Male or female participants from 2 years up to 14 years old.

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

Additional Information

Official title Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
Principal investigator Satinder Aneja, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Lady Hardinge Medical College.