NCT06438562

Evaluation of Vitamin A Absorption From Fortified Bouillon

Evaluation of Vitamin A Absorption From Fortified Bouillon Using Post-prandial Retinyl Ester Response in Comparison With an Oil-based Vitamin A Supplement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers
• Vitamin A

Interventions

Type	Name	Description
OTHER	Unfortified bouillon plus vitamin A in oil	Participants consume unfortified bouillon with vitamin A oil
OTHER	Bouillon fortified with vitamin A #1 plus unfortified oil	Participants consume vitamin A #1 fortified bouillon plus unfortified oil
OTHER	Bouillon fortified with vitamin A #2 plus unfortified oil	Participants consume vitamin A #2 fortified bouillon plus unfortified oil

Timeline

• Start date: 2024-07-10
• Primary completion: 2025-11-27
• Completion: 2025-12-08
• First posted: 2024-06-03
• Last updated: 2026-01-15

Locations

2 sites across 2 countries: United States, Zambia