Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT02825758
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2016-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet
Sponsor:
Vitaflo International, Ltd
Organization:
Study Overview
Official Title:
A Study to Evaluate the Acceptability of ZestiVits; a New Vitamin, Mineral and Trace Element Supplement for Those Aged 11 and Over on a Ketogenic or Restricted Diet With Regard to Product Tolerance, Palatability and Compliance
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:
ZestiVits
Brief 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.
Detailed Description:
To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet.
* Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
* Collection of daily data about the gastro-intestinal tolerance of the study product.
* Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
* Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.
* Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
* Collection of daily data about the gastro-intestinal tolerance of the study product.
* Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
* Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 209722 | OTHER | IRAS | View |