Measuring how well vitamin A is absorbed from fortified bouillon
Evaluation of Vitamin A Absorption From Fortified Bouillon Using Post-prandial Retinyl Ester Response in Comparison With an Oil-based Vitamin A Supplement
This study tests how well different types of vitamin A added to bouillon are absorbed by healthy women aged 18 to 49 to find the best option for improving vitamin A levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 3 sites (Madison, Wisconsin and 2 other locations) |
| Trial ID | NCT06438562 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the absorption of different formulations of vitamin A palmitate when added to bouillon. Healthy adult women aged 18 to 49 will participate in a crossover design, consuming various bouillon treatments and undergoing blood sampling to measure vitamin A levels. The study seeks to determine which formulation is most effective in enhancing vitamin A absorption, addressing a significant public health issue related to vitamin A deficiency in low-income regions.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, nonpregnant women aged 18 to 49 with a BMI between 18.5 and 30.0.
Not a fit: Patients who are currently pregnant, breastfeeding, or have certain health conditions such as active eating disorders or chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for improving vitamin A intake in populations at risk of deficiency.
How similar studies have performed: While the approach of fortifying bouillon with vitamin A is promising, this specific study design is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin and 2 other locations
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
- Tropical Diseases Research Centre — Ndola, Zambia (Not_yet_recruiting)
- Tropical Diseases Research Centre - Field Office — Rufunsa, Zambia (Not_yet_recruiting)
Study contacts
- Principal investigator: Sherry Tanumihardjo, PhD — University of Wisconsin, Madison
- Study coordinator: Bryan Gannon, PhD
- Email: bgannon@wisc.edu
- Phone: 608-265-2026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.