Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438562
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-21
Brief Title:
Evaluation of Vitamin A Absorption From Fortified Bouillon
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Evaluation of Vitamin A Absorption From Fortified Bouillon Using Post-prandial Retinyl Ester Response in Comparison With an Oil-based Vitamin A Supplement
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this clinical trial is to measure how well different formulations of vitamin A VA are absorbed by the body when they are added to bouillon broth as vitamin A palmitate VAP Fortifying bouillon cubes with VA is one potential approach to addressing VA deficiency which is a major public health issue in many low- and lower-income countries The main question this study aims to answer is to compare the amount of VA that is absorbed by the body from three different VAP formulations that are added to bouillon
Participants will consume different formulations of VA and have multiple blood collections
Participants will consume different formulations of VA and have multiple blood collections
Detailed Description:
This study is being conducted to help characterize the absorption of 3 different formulations of VAP PFH-VAP and BASF-VAP250 vs a positive control when prepared as broth with an oil dose containing VAP or placebo referred to as the study treatments and consumed by healthy adult women of reproductive age ages 18 - 49 years
Participants will undergo 3 treatment periods and will be blinded to treatment sequence using a 3-period 3-treatment crossover design to receive all 3 treatments All 3 treatment periods will include blood sampling to measure VA levels from pre- through 24 hours post-broth consumption
Participants will undergo 3 treatment periods and will be blinded to treatment sequence using a 3-period 3-treatment crossover design to receive all 3 treatments All 3 treatment periods will include blood sampling to measure VA levels from pre- through 24 hours post-broth consumption
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Version 10192023 | OTHER | UW- Madison | None |
| A074600 | OTHER | None | None |
| CALSNUTRITIONAL SCIENCES | OTHER | None | None |