Clinical trial NCT02825758: Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet
Official title: A Study to Evaluate the Acceptability of ZestiVits; a New Vitamin, Mineral and Trace Element Supplement for Those Aged 11 and Over on a Ketogenic or Restricted Diet With Regard to Product Tolerance, Palatability and Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency of Micronutrients
Keywords: Micronutrients
restricted
ketogenic
diet
acceptability
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.

Detailed description: To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet.

* 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 products available for use in a ketogenic or restricted therapeutic diet.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet
2. On a ketogenic or restricted therapeutic diet with good compliance
3. Aged 11 years and over
4. Has a requirement for a micronutrient supplement
5. Written informed consent by subject or parent/carer

Exclusion Criteria:

1. Participants aged less than 11 years
2. Use of additional micronutrient supplements during the study period unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)

Primary outcomes:
measure: Palatability via qualitative assessments from a subject questionnaire
timeFrame: 7 days
measure: Gastrointestinal tolerance via qualitative assessments from a subject questionnaire
timeFrame: 7 days
measure: Patient compliance via qualitative assessments from a subject questionnaire
timeFrame: 7 days
measure: Ease of use of product via qualitative assessments from a subject questionnaire
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Avon
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
state: West Yorkshire
Study officials:
affiliation: Northern Care Alliance NHS Foundation Trust
name: Gisela Wilcox
role: PRINCIPAL_INVESTIGATOR
References: