N/A
N=11
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Seizure Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02229318 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Acceptability of FruitiVits — 8; 10; 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FruitiVits (Dietary_supplement)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Vitaflo International, Ltd
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of FruitiVits |
8; 10; 6; 6 | — |
| SECONDARY Ease of Preparation of FruitiVits |
11 | — |
Summary
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of condition requiring a Ketogenic diet
- Currently on a Ketogenic diet
- Aged 4 - 8 years
- Routinely taking a complete micronutrient supplement
- Oral feeding
Exclusion Criteria
- Children aged less than 4 years or older than 9 years of age
Data sourced from ClinicalTrials.gov (NCT02229318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.