Deficiency of MicronutrientsZestiVitsNCT02825758
Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet
A study testing ZestiVits in people with Deficiency of Micronutrients, run by Vitaflo International, Ltd at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Deficiency of Micronutrients
- What is being tested?
- ZestiVits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 17 Feb 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bristol Royal Hospital for Children
Bristol, Avon, BS2 8BJ
Leeds Children's Hospital
Leeds, West Yorkshire, LS1 3EX
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
About this study
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
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.
Read the 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.
- Conditions
- Deficiency of Micronutrients
- Being tested
- ZestiVits
- Keywords
- Micronutrients, restricted, ketogenic, diet, acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZestiVitsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: ZestiVits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability via qualitative assessments from a subject questionnaire
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Measured: 7 days
Gastrointestinal tolerance via qualitative assessments from a subject questionnaire
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Measured: 7 days
Patient compliance via qualitative assessments from a subject questionnaire
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start17 Feb 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency of MicronutrientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gisela Wilcox, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825758
- Sponsor's protocol ID
- MCT-Zest-14/01/2016-01
- Other IDs
- 209722
- Acronym
- ZestiVits
- Status last verified
- Feb 2024
- First submitted
- 24 Jun 2016
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02825758
- Acronym / sponsor ID
- ZestiVits / MCT-Zest-14/01/2016-01
- Conditions
- Deficiency of Micronutrients
- Keywords
- Micronutrients, restricted, ketogenic, diet, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZestiVits | Experimental | Dietary Supplement: ZestiVitsSupplement 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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZestiVitsThe 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. | Dietary supplement | ZestiVits |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisela Wilcox principal investigator
Northern Care Alliance NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZestiVits in people with Deficiency of Micronutrients, run by Vitaflo International, Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability via qualitative assessments from a subject questionnaire (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.