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

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ClinicalTrials.gov Identifier: NCT02825758
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Deficiency of Micronutrients Dietary Supplement: ZestiVits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.





Primary Outcome Measures :
  1. Palatability via qualitative assessments from a subject questionnaire [ Time Frame: 7 days ]
    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  2. Gastrointestinal tolerance via qualitative assessments from a subject questionnaire [ Time Frame: 7 days ]
    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  3. Patient compliance via qualitative assessments from a subject questionnaire [ Time Frame: 7 days ]
    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  4. Ease of use of product via qualitative assessments from a subject questionnaire [ Time Frame: 7 days ]
    Qualitative outcome measures will be described in a narrative summarising the study outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825758


Locations
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United Kingdom
Bristol Royal Hospital for Children
Bristol, Avon, United Kingdom, BS2 8BJ
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 8HD
Leeds Children's Hospital
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Principal Investigator: Gisela Wilcox Salford Royal NHS Foundation Trust
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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02825758    
Other Study ID Numbers: MCT-Zest-14/01/2016-01
209722 ( Other Identifier: IRAS )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitaflo International, Ltd:
Micronutrients
restricted
ketogenic
diet
acceptability