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

Not Applicable

Completed

• Conditions: Deficiency of Micronutrients
• Interventions: Dietary Supplement: ZestiVits

• Registration Number: NCT02825758
• Lead Sponsor: Vitaflo International, Ltd

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.

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2017-02-17
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZestiVits	ZestiVits	Supplement for use in ketogenic and restricted therapeutic diets, from the age of 11. Daily use for 7 days. Daily intake level for each subject will be determined and prescribed by a dietitian.

Primary Outcome Measures

Name	Time	Method
Palatability via qualitative assessments from a subject questionnaire	7 days	Qualitative outcome measures will be described in a narrative summarising the study outcomes
Gastrointestinal tolerance via qualitative assessments from a subject questionnaire	7 days	Qualitative outcome measures will be described in a narrative summarising the study outcomes
Patient compliance via qualitative assessments from a subject questionnaire	7 days	Qualitative outcome measures will be described in a narrative summarising the study outcomes
Ease of use of product via qualitative assessments from a subject questionnaire	7 days	Qualitative outcome measures will be described in a narrative summarising the study outcomes

Trial Locations

Locations (3)

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, United Kingdom