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

NCT05591508 | Unknown DMC

• 1 other identifier: IEC-140/06.03.2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Status Epilepticus; Ketogenic Dieting

Outcome Measures

Primary Outcomes (1)

• 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

  To evaluate the efficacy of add on ketogenic diet therapy compared to standard treatment and care in infants, children and adolescents aged 6 months to 18 years in terms of time taken (in days) for cessation of electrographic status epilepticus immediately after stoppage of convulsive status epilepticus.

  30 Months

Study Arms (2)

A, Intervention Arm

EXPERIMENTAL

Ketogenic Diet +Standard care of Status epilepticus according to current guideline of management

Dietary Supplement: Ketogenic Diet

B, No Intervention Arm

NO INTERVENTION

Standard care of Status Epilepticus according to current guidelines of management

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

Ketogenic diet will be in the form of artificial powder which can be diluted and given through NG tube. It will be started at a ratio of 1:1 followed by daily increment (2:1,3:1 and 4:1) till a urine ketone of 2+ is seen

A, Intervention Arm

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Prof. Sheffali Gulati

New Delhi, National Capital Territory of Delhi, 110049, India

RECRUITING

MeSH Terms

Conditions

Status Epilepticus

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Sheffali Gulati

CONTACT

01126594679; sheffaligulati@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sheffali Gulati , Department of Pediatrics

Model Details: Open labeled randomized controlled trial

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 24, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)