EpilepsyiKETOCHECKNCT05377762
Validation of an Italian Questionnaire of Adherence to the Ketogenic Diet
An observational study of Epilepsy, run by University of Pavia at 2 sites in Italy.
Trial summary
The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age based on normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Epilepsy
- How many people
- 105 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Mar 2022to Sep 2022
- Phase
- Observational
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients treated with a ketogenic diet for more than three months belonging to the Center for Childhood and Adolescent Epileptology of the Mondino Foundation of Pavia will be enrolled, who will accept to participate in the study and will have signed the relative informed consent. For patients under the age of 18, the answers to the questionnaire and the related informed consent must be provided by the parents or legal guardian.
Who may be able to join
- Age <60 years
- Gender: both sexes
- Route of administration of the diet: totally or partially oral
- Diagnosis: drug-resistant epilepsy or GLUT1 deficiency
- Duration of treatment with the ketogenic diet: at least 3 months
- Informed consent of the patient and / or an authorized caregiver / legal representative•
Who cannot join
- Age > 60 years
- Route of administration of the exclusively enteral or parenteral diet
- Duration of treatment with KD less than 3 months
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Pavia
Pavia, 27100
Center for Childhood and Adolescent Epileptology of the Mondino Foundation
Pavia
About this study
Official title: Validation of an Italian Questionnaire of Adherence to the Ketogenic Diet: iKetoCheck
The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age based on normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen. Adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.
Read the detailed description
The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age and is the gold standard therapy for type I glucose transporter deficiency syndrome (GLUT1 DS). According to international guidelines, once undertaken, the KD must be continued for at least three months in order to determine its effectiveness and can be continued for years if effective.
In summary, KD is a normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen that determines in the organism a state of ketosis similar to that induced by a prolonged fast, which corresponds to average levels of ketonemia equal to 2.5 mmol / L.
Not being able to estimate the concentration of ketone bodies in the brain, the serum measurement is adopted, i.e. the detection of capillary ketonemia. It is important to consider the presence of inter-individual and intra-individual variability of ketonemia and this can be influenced by various factors in addition to the composition of the diet and the ketogenic ratio (fat / protein + carbohydrates): infectious episodes, physical activity, hydration , steroid therapy. Hence the importance of individualized treatment and careful monitoring of adherence to dietary recommendations. The quality of the diet, especially at the beginning of ketogenic therapy, but during the entire follow-up, is essential for achieving optimal levels of ketosis.However, adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. Failure to adhere to KD is mainly attributed to dietary side effects, psychosocial factors, or the dietary restriction itself.
There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet; usually, clinicians ask parents and patients to share the food diary in order to check the calorie intake, the ketogenic ratio and the nutritional composition of the diet. A 'Keto-check' questionnaire was recently developed and validated in Brazil, currently only available in Portuguese, with the aim of providing a tool to measure adherence to the ketogenic diet through simple, easily reproducible questions. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.
- Conditions
- Epilepsy
- Keywords
- ketogenic diet, adherence, questonnaire
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence score
The answer of questionnaire will generate a score. Minimum value will be 10 points and maximum 50 points. Higher scores mean a better outcome.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start16 Mar 2022
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Valentina De Giorgis, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377762
- Sponsor's protocol ID
- iKETOCHECK
- Acronym
- iKETOCHECK
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Italian Questionnaire of Adherence to the Ketogenic Diet: iKetoCheck
- ClinicalTrials.gov ID
- NCT05377762
- Acronym / sponsor ID
- iKETOCHECK / iKETOCHECK
- Conditions
- Epilepsy
- Keywords
- ketogenic diet, adherence, questonnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 May 2022 (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.
The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age based on normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen. Adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.
Detailed description
The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age and is the gold standard therapy for type I glucose transporter deficiency syndrome (GLUT1 DS). According to international guidelines, once undertaken, the KD must be continued for at least three months in order to determine its effectiveness and can be continued for years if effective.
In summary, KD is a normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen that determines in the organism a state of ketosis similar to that induced by a prolonged fast, which corresponds to average levels of ketonemia equal to 2.5 mmol / L.
Not being able to estimate the concentration of ketone bodies in the brain, the serum measurement is adopted, i.e. the detection of capillary ketonemia. It is important to consider the presence of inter-individual and intra-individual variability of ketonemia and this can be influenced by various factors in addition to the composition of the diet and the ketogenic ratio (fat / protein + carbohydrates): infectious episodes, physical activity, hydration , steroid therapy. Hence the importance of individualized treatment and careful monitoring of adherence to dietary recommendations. The quality of the diet, especially at the beginning of ketogenic therapy, but during the entire follow-up, is essential for achieving optimal levels of ketosis.However, adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. Failure to adhere to KD is mainly attributed to dietary side effects, psychosocial factors, or the dietary restriction itself.
There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet; usually, clinicians ask parents and patients to share the food diary in order to check the calorie intake, the ketogenic ratio and the nutritional composition of the diet. A 'Keto-check' questionnaire was recently developed and validated in Brazil, currently only available in Portuguese, with the aim of providing a tool to measure adherence to the ketogenic diet through simple, easily reproducible questions. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients treated with a ketogenic diet for more than three months belonging to the Center for Childhood and Adolescent Epileptology of the Mondino Foundation of Pavia will be enrolled, who will accept to participate in the study and will have signed the relative informed consent. For patients under the age of 18, the answers to the questionnaire and the related informed consent must be provided by the parents or legal guardian.
Key inclusion criteria (6 listed)
- Age <60 years
- Gender: both sexes
- Route of administration of the diet: totally or partially oral
- Diagnosis: drug-resistant epilepsy or GLUT1 deficiency
- Duration of treatment with the ketogenic diet: at least 3 months
Key exclusion criteria (3 listed)
- Age > 60 years
- Route of administration of the exclusively enteral or parenteral diet
- Duration of treatment with KD less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence score
Time frame: Through study completion, an average of 6 months
The answer of questionnaire will generate a score. Minimum value will be 10 points and maximum 50 points. Higher scores mean a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Valentina De Giorgis principal investigator
University of Pavia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of Pavia at 2 sites in Italy.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
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?
Adherence score (time frame: Through study completion, an average of 6 months). 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 22 Jun 2022.