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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Simplified Modified Atkins Diet||
Other: Simplified Modified Atkins Diet
Modified Atkins diet with the following modifications:
|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
- 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 ]
- 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.
- Proportion of patients withdrawing from the simplified modified Atkins diet plus antiepileptic drug treatment group during the study period [ Time Frame: 3 months ]
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
|Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital|
|New Delhi, Delhi, India, 110001|
|Principal Investigator:||Satinder Aneja, MD||Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital|