UnknownNot Applicable

Ketogenic Diet for Status Epilepticus in Children Post Cessation of Convulsive Status Epilepticus

India50 participantsStarted 2022-11-01

Plain-language summary

Ketogenic diet being started early in those with status epilepticus and frequent or abundant discharges in EEG in comparison to just standard therapy is being evaluated here for efficacy and adverse effects.

Who can participate

Age range

6 Months – 18 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

. Infants, children and adolescents aged 6 months to 18 years
. Electrographic status
. Clinical status controlled immediately on standard therapy and care based on established consensus guidelines followed globally

Exclusion criteria

. Circulatory failure
. GI Intolerance
. Associated chronic systemic illness
. Any abnormality on baseline laboratory investigation
. Neurometabolic disorders (except those in which ketogenic diet is therapy of choice)

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

Ketogenic diet for electrographic status epilepticus in infants, children and adolescents aged 6 months to 18 years immediately after cessation of convulsive status epilepticus; a randomized open labelled trial

Timeframe: 30 Months

Trial details

NCT IDNCT05591508

SponsorAll India Institute of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

Contact for this trial

Sheffali Gulati

01126594679 sheffaligulati@gmail.com

View on ClinicalTrials.gov More Status Epilepticus trials