Evaluation of Vitamin A Absorption From Fortified Bouillon

Launched by UNIVERSITY OF WISCONSIN, MADISON · May 29, 2024

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