Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432231
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-18
Brief Title:
Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy
Sponsor:
Izmir Katip Celebi University
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency Oxidative Stress Mental Health and Health-related Quality of Life in Children With Drug-resistant Epilepsy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet LGID on seizure frequency oxidative stress markers and quality of life in children with drug-resistant epilepsy Based upon the aims the following hypotheses were tested
1 LGID reduces seizure frequency in children with drug-resistant epilepsy
2 LGID improves oxidative parameters in children with drug-resistant epilepsy
3 LGID improves quality of life and mental health in children with drug-resistant epilepsy
Participants were prescribed the LGID for 3 monthsAt baseline and at outpatient clinic follow-ups at 3 months anthropometric measurements were taken the strengths and difficulties questionnaire SDQ Pediatric Inventory of Quality of Life PedsQL and depression scales were administered and samples for biochemical measurements were collected Diet compliance was evaluated by food consumption records during monthly follow-up visits at 1 2 and 3 months
1 LGID reduces seizure frequency in children with drug-resistant epilepsy
2 LGID improves oxidative parameters in children with drug-resistant epilepsy
3 LGID improves quality of life and mental health in children with drug-resistant epilepsy
Participants were prescribed the LGID for 3 monthsAt baseline and at outpatient clinic follow-ups at 3 months anthropometric measurements were taken the strengths and difficulties questionnaire SDQ Pediatric Inventory of Quality of Life PedsQL and depression scales were administered and samples for biochemical measurements were collected Diet compliance was evaluated by food consumption records during monthly follow-up visits at 1 2 and 3 months
Detailed Description:
The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency oxidative stress markers and quality of life in children with drug-resistant epilepsyThis study was a prospective non-randomized single centre intervention conducted in children with drug-resistant epilepsy Low glycemic index diet was started on an out-patient basis Children and their parents were educated about the diet and the effect of the diet on seizures Children who were willing to follow the diet were included in the study The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the dietAt baseline and at outpatient clinic follow-ups at 3 months anthropometric measurements were taken the strengths and difficulties questionnaire SDQ Pediatric Inventory of Quality of Life PedsQL and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance Parents were asked to record the seizure frequency and severity in a seizure diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None