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

NCT02825758 | Completed

• 2 other identifiers: MCT-Zest-14/01/2016-01209722
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Deficiency of Micronutrients

Keywords

Micronutrients; restricted; ketogenic; diet; acceptability

Outcome Measures

Primary Outcomes (4)

• Palatability via qualitative assessments from a subject questionnaire

  Qualitative outcome measures will be described in a narrative summarising the study outcomes

  7 days

• Gastrointestinal tolerance via qualitative assessments from a subject questionnaire

  Qualitative outcome measures will be described in a narrative summarising the study outcomes

  7 days

• Patient compliance via qualitative assessments from a subject questionnaire

  Qualitative outcome measures will be described in a narrative summarising the study outcomes

  7 days

• 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

Study Arms (1)

ZestiVits

EXPERIMENTAL

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.

Dietary Supplement: ZestiVits

Interventions

ZestiVits DIETARY_SUPPLEMENT

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.

ZestiVits

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants aged less than 11 years
• 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)

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

Study Sites (3)

Bristol Royal Hospital for Children

Bristol, Avon, BS2 8BJ, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Leeds Children's Hospital

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Study Officials

• Gisela Wilcox

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 7, 2016
• Study Start: February 17, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)