Status:
COMPLETED
Market Research - Acceptability Study for New MCT Fat Products
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
Ketosis
Epilepsy
Eligibility:
All Genders
3-20 years
Phase:
NA
Brief Summary
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD f...
Eligibility Criteria
Inclusion
- Diagnosis of epilepsy requiring a ketogenic or a specialist diet as part of their treatment.
- Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled.
- Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study.
- Patients aged 3 years of age to adulthood.
- Written informed consent obtained from patient or parental caregiver.
Exclusion
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study
- Patients already on and MCT product who have been taking it in their diet for less than 4 weeks
- Patients less than 3 years of age
- Patients over 20 years.
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04309214
Start Date
November 26 2018
End Date
January 21 2019
Last Update
March 16 2020
Active Locations (1)
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1
Royal Aberdeen Children's Hospital
Aberdeen, Grampian, United Kingdom, AB25 2ZG