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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT02915211 |
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Date of registration:
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19/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Keyo in Children With Epilepsy
Keyo |
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Scientific title:
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A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02915211 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Helen McCullagh, BSc, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Leeds Teaching Hospitals NHS Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 3 years and over
- Confirmed diagnosis of intractable epilepsy or Glut-1 DS
- Children must be currently established on a KD for at least 3 months, taken orally
- Written, informed consent by participant/carer
Exclusion Criteria:
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Age minimum:
3 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glucose Transporter Type 1 Deficiency Syndrome
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Ketogenic Dieting
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Intractable Epilepsy
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Intervention(s)
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Dietary Supplement: Keyo
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Primary Outcome(s)
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Palatability questionnaire
[Time Frame: Day 8]
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Ease of use daily diary
[Time Frame: Days 1-7]
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GI tolerance daily diary
[Time Frame: Days 1-7]
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Product compliance daily diary
[Time Frame: Days 1-7]
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Secondary ID(s)
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196542
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MCT-Keyo-11/12/15-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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