Evaluation of Ketoflo (Ketoflo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04399954|
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : September 19, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Intractable Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting||Dietary Supplement: Ketoflo||Not Applicable|
This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI tolerance, adherence to recommended intakes and palatability. The product's nutritional suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and seizure frequency measured as part of usual clinical care.
Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy or other neurometabolic conditions requiring a ketogenic diet. It is designed to be nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.
Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional choice of prescribe-able feeds for use in the ketogenic diet.
The study will involve 30 participants, aged between three and eighteen years of age (inclusive), who are already established on a ketogenic diet for at least three months before the study begins.
Participants will self-report data in Daily Study Diaries over the course of the study. Data will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all participants. Any data collected for the study will be anonymised before being relayed to the sponsor.
The data generated by the trial will be used to support a submission by Vitaflo (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to become reimbursable on prescription in the UK. The data will also be used in a submission to the General Medical Services in the Republic of Ireland.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group - all patients to receive Ketoflo.|
|Masking:||None (Open Label)|
|Masking Description:||No masking, product will be given open label.|
|Primary Purpose:||Supportive Care|
|Official Title:||A Study to Evaluate the Acceptability of Ketoflo, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Epilepsy or Neurometabolic Conditions Requiring a Ketogenic Diet (KD)|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||March 31, 2024|
Ketoflo to be incorporated into each participant's usual ketogenic diet for 28 days. Amount taken and frequency of intake to be determined by the dietitian.
Dietary Supplement: Ketoflo
Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.
- Change in gastrointestinal tolerance from week 1 to week 4 [ Time Frame: Days 1 - 7 and days 21 - 28. ]Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.
- Adherence [ Time Frame: Days 1 - 28. ]Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.
- Palatability and ease of use [ Time Frame: Day 28. ]Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.
- Nutritional suitability: ketone levels [ Time Frame: Days 1 - 28 ]Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
- Nutritional suitability: seizure frequency [ Time Frame: Days 1 - 28 ]Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||3 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
i) Diagnosis of a condition requiring a ketogenic diet (KD) e.g. intractable epilepsy, Glut-1 deficiency syndrome (Glut-1 DS) etc.
ii) Aged 3 - 18 years of age (inclusive).
iii) Established on a ketogenic diet for at least 3 months under the supervision of a clinician and/or dietitian trained in the use of the KD.
iv) Requirement for a liquid ketogenic feed.
v) In the opinion of the investigator, the participant (and parent/guardian, if relevant) is/are able to comply with the study protocol requirements and complete the diary and questionnaire.
vi) Willingly given, written, informed consent from participant (or parent/guardian, if relevant)
vii) Willingly given, written assent (if appropriate).
i) Inability to comply with the study protocol, in the opinion of the investigator.
ii) Under 3 years of age or over 18 years of age.
iii) Medical conditions in which the KD is contraindicated.
iv) Previous clinical evaluation indicating unsuitability for the KD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399954
|Contact: Grace Thomas||01517099020||Grace.Thomas@Vitaflo.co.uk|
|Contact: Erika Brennan||1517099020 ext 262||Erika.Brennan@vitaflo.co.uk|
|Royal Aberdeen Children's Hospital||Not yet recruiting|
|Aberdeen, United Kingdom, AB25 2ZG|
|Contact: Tracey Cameron Tracey.Cameron1@NHS.Scot|
|Birmingham, United Kingdom, B15 2SY|
|Contact: Manny Bagary M.Bagary@NHS.Net|
|Bristol Royal Hospital for Children||Recruiting|
|Bristol, United Kingdom, BS2 8BJ|
|Contact: Camille Newby Camille.Newby@UHBW.NHS.UK|
|Tayside Children's Hospital||Not yet recruiting|
|Dundee, United Kingdom, DD1 9SY|
|Contact: Tracey Cameron Tracey.Cameron1@NHS.Scot|
|Leeds Children's Hospital||Recruiting|
|Leeds, United Kingdom, LS1 3EX|
|Contact: Kathryn Lightfoot Kathryn.Lightfoot@NHS.Net|
|Great Ormond Street Hospital for Children||Recruiting|
|London, United Kingdom, WC1N 3JH|
|Contact: Zoe Simpson Zoe.Simpson@GOSH.NHS.UK|
|Study Director:||Kathryn Lightfoot||Leeds Teaching Hospitals NHS Trust|
|Principal Investigator:||Victoria Whiteley||Manchester University NHS Foundation Trust|
|Responsible Party:||Vitaflo International, Ltd|
|Other Study ID Numbers:||
|First Posted:||May 22, 2020 Key Record Dates|
|Last Update Posted:||September 19, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||No plans to share IPD.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Drug Resistant Epilepsy
Central Nervous System Diseases
Nervous System Diseases