Status:
COMPLETED
Evaluation of Ketoflo
Lead Sponsor:
Vitaflo International, Ltd
Conditions:
Epilepsy Intractable
Glucose Transporter Type 1 Deficiency Syndrome
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally comp...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04399954
Start Date
February 24 2020
End Date
June 30 2023
Last Update
February 15 2024
Active Locations (5)
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1
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom, AB25 2ZG
2
Barberry
Birmingham, United Kingdom, B15 2SY
3
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
4
Leeds Children's Hospital
Leeds, United Kingdom, LS1 3EX