Ketogenic DietNCT06255873
Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
A study testing L- Carnitine and ketogenic diet in people with Ketogenic Diet, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started… Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Ketogenic Diet
- What is being tested?
- L- Carnitine and ketogenic diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start KD.
Who cannot join
- Patients with intolerance or non-compliance to ketogenic diet therapy.
- Patients for epilepsy surgery or vagal nerve stimulation.
- Children with history of previous abdominal operations.
- Children with history of GI diseases affecting GI motility before starting KD.
- Children with tube feeding or feeding gastrostomy or jejunostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of L-Carnitine Supplementation on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started ketogenic diet only.
- Conditions
- Ketogenic Diet
- Being tested
- L- Carnitine, ketogenic diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L- CarnitineDietary supplement
L-carnitine was taken after feeds in the form of tablets or dissolved tablets in a dose of 50 mg/kg/day, with maximum dose of 2 g/day.
ketogenic dietOther
ketogenic diet (KD) initiated under supervision of expert physician who considered patient's age, type of feeding, needs and preferences of the child and his/her family to select the type and initial ratio of KD therapy, KD ratio ranged from 1:1 to 4:1 of lipids to carbohydrates plus proteins in grams.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet with L - Carnitine supplementation. | Experimental | Patients with drug resistant epilepsy who received ketogenic diet with L - Carnitine supplementation. Receives: Dietary Supplement: L- Carnitine; Other: ketogenic diet |
| ketogenic diet. | Active comparator | Patients with drug resistant epilepsy who received ketogenic diet only. Receives: Other: ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD).
Antral length measurement using abdominal ultrasonography.
Measured: At time of enrollment and 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start20 Jan 2023
- Primary completion22 Sep 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Essam Ibrahim, Ain Shams University
- Investigators
- May F Nassar, MD, Study director, Professor of pediatrics, Faculty of Medicine, Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255873
- Sponsor's protocol ID
- FMASU MS 630/ 2022
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-Carnitine Supplementation on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
- ClinicalTrials.gov ID
- NCT06255873
- Acronym / sponsor ID
- FMASU MS 630/ 2022
- Conditions
- Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started ketogenic diet only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet with L - Carnitine supplementation. | Experimental | Dietary Supplement: L- Carnitine, Other: ketogenic dietPatients with drug resistant epilepsy who received ketogenic diet with L - Carnitine supplementation. |
| ketogenic diet. | Active comparator | Other: ketogenic dietPatients with drug resistant epilepsy who received ketogenic diet only. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start KD.
Key exclusion criteria (5 listed)
- Patients with intolerance or non-compliance to ketogenic diet therapy.
- Patients for epilepsy surgery or vagal nerve stimulation.
- Children with history of previous abdominal operations.
- Children with history of GI diseases affecting GI motility before starting KD.
- Children with tube feeding or feeding gastrostomy or jejunostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L- CarnitineL-carnitine was taken after feeds in the form of tablets or dissolved tablets in a dose of 50 mg/kg/day, with maximum dose of 2 g/day. | Dietary supplement | ketogenic diet with L - Carnitine supplementation. |
| ketogenic dietketogenic diet (KD) initiated under supervision of expert physician who considered patient's age, type of feeding, needs and preferences of the child and his/her family to select the type and initial ratio of KD therapy, KD ratio ranged from 1:1 to 4:1 of lipids to carbohydrates plus proteins in grams. | Other | ketogenic diet with L - Carnitine supplementation., ketogenic diet. |
Primary outcome
Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD).
Time frame: At time of enrollment and 3 months of intervention.
Antral length measurement using abdominal ultrasonography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May F Nassar, MD study director
Professor of pediatrics, Faculty of Medicine, Ain shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L- Carnitine and ketogenic diet in people with Ketogenic Diet, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD). (time frame: At time of enrollment and 3 months of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.