CompletedNot Applicable

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

United Kingdom15 participantsStarted 2017-02-17

Plain-language 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.

Who can participate

Age range11 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Palatability via qualitative assessments from a subject questionnaire

Timeframe: 7 days

Gastrointestinal tolerance via qualitative assessments from a subject questionnaire

Timeframe: 7 days

Patient compliance via qualitative assessments from a subject questionnaire

Timeframe: 7 days

Ease of use of product via qualitative assessments from a subject questionnaire

Timeframe: 7 days

Trial details

NCT IDNCT02825758

SponsorVitaflo International, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-31

View on ClinicalTrials.gov More Deficiency of Micronutrients trials