Evaluation of Vitamin A Absorption From Fortified Bouillon

Description

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.

Conditions

Healthy Volunteers, Vitamin A

Study Overview

Study Details

Study overview

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.

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

Evaluation of Vitamin A Absorption From Fortified Bouillon

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy, nonpregnant women
  • * ≥18 and \<49 years of age
  • * Able and willing to provide informed consent
  • * Body mass index (BMI) between 18.5 to 30.0 kg/m2
  • * Willing and able to undergo study procedures, including: repeated blood sampling, a baseline hemoglobin and pregnancy test, adherence to a low-vitamin A diet at specified times throughout the study, consumption of provided meals (specifically, a breakfast of bouillon, peanut butter, and a bagel or bread), and, except for the Screening visit, foregoing alcohol for at least 2 days before each visit and fasting for ≥8 hours before each visit
  • * Currently pregnant
  • * Breastfeeding a child under 1 year of age
  • * Allergic to soy or peanut butter
  • * Current use of smoking tobacco products or any other form of nicotine
  • * Active eating disorder diagnosis
  • * Current diagnosis of acute or chronic illness, including hepatitis, Celiac's disease, Crohn's disease, and cystic fibrosis
  • * Moderate or severe anemia according to World Health Organization guidelines (i.e., hemoglobin ≤10.9 g/dL)
  • * Unable or unwilling to refrain from consuming alcohol when required
  • * Unable or unwilling to discontinue consumption of foods that are high in vitamin A and of vitamin A supplements when required during the study
  • * Taking prescription oral medication that includes a retinoid, e.g., isotretinoin/ Accutane
  • * Taking proton pump inhibitors.
  • * Unable/unwilling to avoid taking antacids during the fasting period prior to sample collection
  • * Unable/unwilling to fast for periods of at least 10 hours at a time
  • * Status relationship with a member of the study team.
  • * Unable to fulfill study requirements per the judgment of the investigator

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Wisconsin, Madison,

Sherry Tanumihardjo, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Bryan M Gannon, PhD, STUDY_DIRECTOR, University of Wisconsin, Madison

Luke M Funk, MD, MPH, STUDY_DIRECTOR, University of Wisconsin, Madison

Justin Chileshe, PhD, STUDY_DIRECTOR, Tropical Diseases Research Centre, Zambia

Study Record Dates

2025-12