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Evaluation of Keyo in Children With Epilepsy (Keyo)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915211
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Vitaflo International, Ltd

Tracking Information
First Submitted Date  ICMJE September 19, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date September 26, 2016
Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Palatability questionnaire [ Time Frame: Day 8 ]
    Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
  • Ease of use daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
  • GI tolerance daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
  • Product compliance daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Keyo in Children With Epilepsy
Official Title  ICMJE 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
Brief Summary To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Detailed Description

Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.

Collection of daily data about the gastro-intestinal tolerance of the study product.

Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.

Improve quality of life by increasing range of foods available for use in a ketogenic diet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intractable Epilepsy
  • Glucose Transporter Type 1 Deficiency Syndrome
  • Ketogenic Dieting
Intervention  ICMJE Dietary Supplement: Keyo
Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD.
Study Arms  ICMJE Experimental: Consumption of Keyo
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
Intervention: Dietary Supplement: Keyo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2016)		 17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02915211
Other Study ID Numbers  ICMJE MCT-Keyo-11/12/15-01
196542 ( Other Identifier: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Vitaflo International, Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vitaflo International, Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helen McCullagh, BSc, MBChB Leeds Teaching Hospitals NHS Trust
PRS Account Vitaflo International, Ltd
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP