60 Participants Needed

Fortified Bouillon for Vitamin A Absorption

Recruiting at 2 trial locations
BG
BM
Overseen ByBryan M Gannon, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

LM

Luke M Funk, MD, MPH

Principal Investigator

University of Wisconsin, Madison

JC

Justin Chileshe, PhD

Principal Investigator

Tropical Diseases Research Centre, Zambia

ST

Sherry Tanumihardjo, PhD

Principal Investigator

University of Wisconsin, Madison

BM

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

Healthy, nonpregnant women
Able and willing to provide informed consent
Body mass index (BMI) between 20 to 30 kg/m2
See 1 more

Exclusion Criteria

Currently pregnant
Breastfeeding a child under 1 year of age
Unable or unwilling to refrain from consuming alcohol when required
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

3 periods
Multiple visits for each treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Vitamin A
Trial Overview The study is testing how well the body absorbs Vitamin A from three different types of fortified bouillon compared to unfortified bouillon with added vitamin A oil. It aims to identify the most effective formulation.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin A #2Experimental Treatment1 Intervention
Bouillon fortified with vitamin A formulation #2 plus unfortified oil
Group II: Vitamin A #1Experimental Treatment1 Intervention
Bouillon fortified with vitamin A formulation #1 plus unfortified oil
Group III: Unfortified bouillon positive controlActive Control1 Intervention
Unfortified bouillon plus vitamin A fortified oil

Vitamin A is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Vitamin A for:
  • Vitamin A deficiency
  • Prevention of night blindness
  • Supportive therapy in measles
🇪🇺
Approved in European Union as Vitamin A for:
  • Vitamin A deficiency
  • Prevention of night blindness
  • Supportive therapy in measles
🇨🇦
Approved in Canada as Vitamin A for:
  • 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

Trials
1,249
Recruited
3,255,000+

Particles for Humanity, PBC

Industry Sponsor

Trials
1
Recruited
60+

Tropical Diseases Research Centre, Zambia

Collaborator

Trials
10
Recruited
12,800+

Findings from Research

Increased consumption of carotene-rich fruits and vegetables is associated with better vitamin A status, but this relationship is not definitively causal due to limitations in study designs and conflicting results from recent experiments.
Factors such as the type of carotene, meal composition, and individual host characteristics significantly influence the bioavailability of carotenoids and their conversion to vitamin A, indicating that more research is needed to understand these dynamics.
Dietary carotenoids and their role in combating vitamin A deficiency: a review of the literature.de Pee, S., West, CE.[2005]
Encapsulating vitamin A in a special copolymer significantly improves its stability during cooking and storage, making it a more effective option for food fortification against vitamin A deficiency.
In a study with healthy premenopausal women, the encapsulated vitamin A was absorbed similarly to free vitamin A, suggesting that this technology can effectively deliver vitamin A in fortified foods.
Enhanced stability and clinical absorption of a form of encapsulated vitamin A for food fortification.Tang, W., Zhuang, J., Anselmo, AC., et al.[2023]
Vitamin A deficiency (VAD) affects around 125-130 million preschool-aged children, increasing their risk of serious health issues, but vitamin A supplementation and food fortification can significantly reduce this risk and improve child survival.
Recent risk management tools allow for the safe use of vitamin A in food fortification, ensuring that populations in low-resource countries can increase their intake without exceeding safe limits, especially since carotenoid sources pose no overdose risk.
Are low tolerable upper intake levels for vitamin A undermining effective food fortification efforts?Kraemer, K., Waelti, M., de Pee, S., et al.[2019]

References

Dietary carotenoids and their role in combating vitamin A deficiency: a review of the literature. [2005]
Enhanced stability and clinical absorption of a form of encapsulated vitamin A for food fortification. [2023]
Are low tolerable upper intake levels for vitamin A undermining effective food fortification efforts? [2019]
Systematic review and meta-analysis approach on vitamin A fortified foods and its effect on retinol concentration in under 10 year children. [2020]
The effect of vitamin A-fortified coconut cooking oil on the serum retinol concentration of Filipino children 4-7 years old. [2017]
[Risk assessment of fortification level for vitamin A in food in China]. [2012]
Fluid milk vitamin fortification compliance in New York State. [2006]
Evaluation of Palm Oil as a Suitable Vegetable Oil for Vitamin A Fortification Programs. [2018]
Vitamin A status and body pool size of infants before and after consuming fortified home-based complementary foods. [2020]
In vitro and in vivo assessment of vitamin A encapsulation in a liposome-protein delivery system. [2019]
Nanoencapsulation approaches for oral delivery of vitamin A. [2021]
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