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A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet. (FruitiVits)

Primary Purpose

Seizure Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FruitiVits
Sponsored by
Vitaflo International, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Seizure Disorders

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of condition requiring a Ketogenic diet
  2. Currently on a Ketogenic diet
  3. Aged 4 - 8 years
  4. Routinely taking a complete micronutrient supplement
  5. Oral feeding

Exclusion Criteria:

1) Children aged less than 4 years or older than 9 years of age

Sites / Locations

  • The Children's Hospital of Philadelphia, Division of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FruitiVits

Arm Description

Daily administration of FruitiVits dietary supplement

Outcomes

Primary Outcome Measures

Acceptability of FruitiVits
The study product was rated on a scale of 1-5: (liked very much) (liked moderately) (neither liked nor disliked) (disliked moderately) (disliked very much).

Secondary Outcome Measures

Ease of Preparation of FruitiVits
Ease of preparation of FruitiVits was rated on a scale of 1-5: (very easy) (moderately easy) (neither easy nor difficult) (moderately difficult) (very difficult). Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients

Full Information

First Posted
August 26, 2014
Last Updated
April 30, 2019
Sponsor
Vitaflo International, Ltd
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02229318
Brief Title
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Acronym
FruitiVits
Official Title
A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitaflo International, Ltd
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizure Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FruitiVits
Arm Type
Experimental
Arm Description
Daily administration of FruitiVits dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
FruitiVits
Intervention Description
Daily administration of FruitiVits dietary supplement
Primary Outcome Measure Information:
Title
Acceptability of FruitiVits
Description
The study product was rated on a scale of 1-5: (liked very much) (liked moderately) (neither liked nor disliked) (disliked moderately) (disliked very much).
Time Frame
Day 8 of trial
Secondary Outcome Measure Information:
Title
Ease of Preparation of FruitiVits
Description
Ease of preparation of FruitiVits was rated on a scale of 1-5: (very easy) (moderately easy) (neither easy nor difficult) (moderately difficult) (very difficult). Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients
Time Frame
Day 8 of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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: 1) Children aged less than 4 years or older than 9 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Bergqvist, M.D
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia, Division of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.

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