Fact CheckerSign in

NCT06432231Completed

Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy

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

Source: ClinicalTrials.gov · Last updated 29 May 2024

Brief summary (registry, in English)

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 months.At 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).

Status (registry)
Completed
Study type
Interventional
Enrollment
34 (actual)
First submitted
18 May 2024
Start date
28 Aug 2022
Primary completion date
20 Feb 2024
Lead sponsor
Izmir Katip Celebi University
Diseases
Epilepsy
NCT number
NCT06432231

What you commit to

  • Study type: Interventional
  • Participants enrolled: 34
  • From 28 Aug 2022 to the primary completion date, 20 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.

Other

  • non-compliance with the diet recommended by the patient and/or parents
  • enteral tube or parenteral feeding

Who the study is looking for

  • Being between the ages of 4-18,
  • being diagnosed with drug-resistant epilepsy,
  • having more than one seizure per week,
  • not having followed a ketogenic diet before.
  • willing to come for regular follow up

Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gamze Yurtdaş Depboylu
Coordinator of this site? Confirm its status
ÇiğliTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.