Last updated: January 23, 2024
Sponsor: Nutricia Nutrition Clinique
Overall Status: Active - Recruiting
Phase
N/A
Condition
Epilepsy
Treatment
Ketocal
Clinical Study ID
NCT06075485
2023-A01073-42
Ages 5-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1day).
- With drug-resistant epilepsy according to ILAE (International League Against Epilepsy)criteria: persistence of epileptic seizures after failure of two appropriateantiepileptic drugs tried consecutively or in well-tolerated combination.
- Indication for CR by a physician.
- Parents (or legal guardians) able to set up and follow the diet, assessed during ajoint doctor-dietician consultation.
- Written authorization from one (or both) parents or the child's legal representativeto collect personal information about their child.
- Affiliation of the infant/child with the social security system.
Exclusion
Exclusion Criteria:
- Contraindication to ketogenic diet at initial assessment.
- Children already on a ketogenic diet.
- Parenteral nutrition.
- Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.
- Protected legal representative (under legal protection, or deprived of liberty byjudicial or administrative decision).
- Legal representative not covered by a social security scheme.
- Legal representative unable to understand study protocol. Ancillary study eligibility criteria :
- Patients included in the study.
- Continued on the ketogenic diet for at least 2 months.
- Having consented to participate in the ancillary study.
Study Design
Total Participants: 133
Treatment Group(s): 1
Primary Treatment: Ketocal
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
June 30, 2026
Study Description
Connect with a study center
CHRU Lille
Lille, 59037
FranceActive - Recruiting
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