Clinical Trial: Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

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.


Detailed Summary:
Sponsor: Lady Hardinge Medical College

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: June 14, 2013
Date Started: April 2013
Date Completion: April 2016
Last Updated: July 11, 2013
Last Verified: July 2013