Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-02 @ 11:13 PM
Study NCT ID:
NCT02229318
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Sponsor:
Vitaflo International, Ltd
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FruitiVits
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: