Evaluation of Keyo in Children With Epilepsy

Vitaflo

Status: Completed

Conditions: Glucose Transporter Type 1 Deficiency Syndrome; Intractable Epilepsy; Ketogenic Dieting

Treatments: Dietary Supplement: Keyo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02915211

MCT-Keyo-11/12/15-01

196542 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Consumption of Keyo

Experimental group

Description:

Participants will consume their normal KD and take Keyo as advised by the lead dietitian.

Treatment:

Dietary Supplement: Keyo