Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment option for refractory epilepsy. However it is very restrictive and requires strict weighing of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this study has been planned to investigate whether there are clear benefits in terms of seizure control in children with refractory epilepsy who are treated with the modified Atkins diet, versus controls.
Who can participate
Age range
2 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.
Exclusion Criteria:
* Known or suspected inborn error of metabolism
* 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
* And/ or 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
* positive results on urine neurometabolic screening tests
* Motivational or psychosocial issues in the family which would preclude compliance
* Systemic illness- chronic hepatic, renal or pulmonary disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group.