Fortified Bouillon for Vitamin A Absorption
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, such as those containing retinoids (like isotretinoin/Accutane) and proton pump inhibitors. If you are taking these, you will need to discontinue them to participate.
What data supports the effectiveness of the treatment Vitamin A, Retinol, Vitamin A1 in fortified bouillon for vitamin A absorption?
Research shows that food fortification with vitamin A, such as using vitamin A-fortified cooking oil, can significantly improve vitamin A levels in children, which suggests that fortified bouillon could also be effective. Additionally, encapsulated vitamin A in food fortification has been shown to improve stability and absorption, indicating potential benefits for vitamin A absorption in fortified bouillon.12345
Is fortified bouillon with vitamin A safe for human consumption?
Vitamin A has been used safely in food fortification programs to address deficiencies, and risk management tools help ensure safe levels are maintained. Concerns about high intake levels are more relevant in affluent countries, while in low-resource areas, the risk of deficiency is greater than the risk of overdose.23678
How does the treatment of fortified bouillon for vitamin A absorption differ from other treatments for vitamin A deficiency?
The fortified bouillon treatment for vitamin A absorption is unique because it likely involves the use of encapsulation techniques to enhance the stability and absorption of vitamin A, similar to methods used in food fortification strategies. This approach may improve vitamin A's bioavailability compared to traditional supplements, which can degrade during storage and cooking.2791011
What is the purpose of this trial?
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.
Research Team
Luke M Funk, MD, MPH
Principal Investigator
University of Wisconsin, Madison
Justin Chileshe, PhD
Principal Investigator
Tropical Diseases Research Centre, Zambia
Sherry Tanumihardjo, PhD
Principal Investigator
University of Wisconsin, Madison
Bryan M Gannon, PhD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
This trial is for healthy individuals interested in helping to find new ways to address Vitamin A deficiency. Participants will need to consume various bouillon formulations with vitamin A and undergo blood tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 3 treatment periods with different vitamin A formulations, including blood sampling to measure vitamin A levels from pre- through 24 hours post-broth consumption
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vitamin A
Vitamin A is already approved in United States, European Union, Canada for the following indications:
- Vitamin A deficiency
- Prevention of night blindness
- Supportive therapy in measles
- Vitamin A deficiency
- Prevention of night blindness
- Supportive therapy in measles
- Vitamin A deficiency
- Prevention of night blindness
- Supportive therapy in measles
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Particles for Humanity, PBC
Industry Sponsor
Tropical Diseases Research Centre, Zambia
Collaborator