Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet

Deficiency of Micronutrients Clinical Trial

— ZestiVits  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825758
• Other study ID #: MCT-Zest-14/01/2016-01
• Secondary ID: 209722
• Status: Completed
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Deficiency of Micronutrients

Intervention

Dietary Supplement:
• ZestiVits
The study product is a low-carbohydrate, orange flavour, vitamin, mineral and trace element (micronutrient) supplement for use in ketogenic and restricted therapeutic diets, for children aged from 11 years of age and adults. The recommended dosage of the study product for each subject will be determined and prescribed by a dietitian. This will be based on individual requirements for micronutrient supplementation.

Locations

Country	Name	City	State
United Kingdom	Bristol Royal Hospital for Children	Bristol	Avon
United Kingdom	Leeds Children's Hospital	Leeds	West Yorkshire
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vitaflo International, Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatability via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Primary	Gastrointestinal tolerance via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Primary	Patient compliance via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Primary	Ease of use of product via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days