FruitiVitsA Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
FruitiVits
Brain Diseases+1
+ Central Nervous System Diseases
+ Epilepsy
Other Study
Summary
Study start date: September 1, 2014
Actual date on which the first participant was enrolled.The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management. Primary Hypothesis: FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet. Secondary Hypothesis: FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 4 to 9 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Children's Hospital of Philadelphia, Division of Neurology
Philadelphia, United StatesOpen The Children's Hospital of Philadelphia, Division of Neurology in Google Maps