Evaluation of Vitamin A Absorption From Fortified Bouillon
Launched by UNIVERSITY OF WISCONSIN, MADISON · May 29, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well different forms of vitamin A, when added to bouillon (a type of broth), are absorbed by the body. The researchers want to find out which formulation works best to help fight vitamin A deficiency, a serious health issue in many countries. The trial is looking for healthy women aged 18 to 49 who meet specific health criteria, such as having a body mass index (BMI) between 20 and 30, and who are willing to follow certain diet restrictions during the study.
Participants can expect to eat meals that include bouillon and have blood samples taken several times to measure how much vitamin A their bodies absorb. It's important for potential participants to know that they will need to avoid alcohol and certain foods high in vitamin A during the study. This trial is currently recruiting, and those interested should be in good health and willing to adhere to the study requirements.
Gender
FEMALE
Eligibility criteria
- Inclusion 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
- Exclusion Criteria:
- • 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
Trial Officials
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
About University Of Wisconsin, Madison
The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ndola, , Zambia
Madison, Wisconsin, United States
Rufunsa, , Zambia
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0