COMPLETED

Evaluation of Vitamin A Absorption From Fortified Bouillon

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Healthy VolunteersVitamin A

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-10
Study Completion:2025-12-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06438562

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.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, nonpregnant women
  2. * ≥18 and \<49 years of age
  3. * Able and willing to provide informed consent
  4. * Body mass index (BMI) between 18.5 to 30.0 kg/m2
  5. * 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
  1. * Currently pregnant
  2. * Breastfeeding a child under 1 year of age
  3. * Allergic to soy or peanut butter
  4. * Current use of smoking tobacco products or any other form of nicotine
  5. * Active eating disorder diagnosis
  6. * Current diagnosis of acute or chronic illness, including hepatitis, Celiac's disease, Crohn's disease, and cystic fibrosis
  7. * Moderate or severe anemia according to World Health Organization guidelines (i.e., hemoglobin ≤10.9 g/dL)
  8. * Unable or unwilling to refrain from consuming alcohol when required
  9. * Unable or unwilling to discontinue consumption of foods that are high in vitamin A and of vitamin A supplements when required during the study
  10. * Taking prescription oral medication that includes a retinoid, e.g., isotretinoin/ Accutane
  11. * Taking proton pump inhibitors.
  12. * Unable/unwilling to avoid taking antacids during the fasting period prior to sample collection
  13. * Unable/unwilling to fast for periods of at least 10 hours at a time
  14. * Status relationship with a member of the study team.
  15. * Unable to fulfill study requirements per the judgment of the investigator

Contacts and Locations

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2025-12-08

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2025-12-08

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Volunteers
  • Vitamin A