Clinical trial NCT06438562: Evaluation of Vitamin A Absorption From Fortified Bouillon
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Vitamin A
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Particles for Humanity, PBC
name: Tropical Diseases Research Centre, Zambia
First posted: 2024-06-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive all 3 study treatments over 3 treatment periods.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: This study is being conducted to help characterize the absorption of 3 different formulations of VAP (PFH-VAP and BASF-VAP250 vs a positive control) when prepared as broth with an oil dose containing VAP or placebo (referred to as the "study treatments") and consumed by healthy adult women of reproductive age (ages 18 - 49 years).

Participants will undergo 3 treatment periods and will be blinded to treatment sequence using a 3-period, 3-treatment crossover design to receive all 3 treatments. All 3 treatment periods will include blood sampling to measure VA levels from pre- through 24 hours post-broth consumption.

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

Primary outcomes:
measure: Serum retinyl ester area-under-the-effect-curve
timeFrame: Baseline to 8 hours
measure: Serum retinyl ester area-under-the-effect-curve
timeFrame: Baseline to 24 hours
Secondary outcomes:
measure: Serum retinol maximum concentration (Cmax)
timeFrame: Baseline to 24 hours
measure: Serum retinyl ester maximum concentration (Cmax)
timeFrame: Baseline to 24 hours
measure: Time to maximum serum retinol concentration (Tmax)
timeFrame: Baseline to 24 hours
measure: Time to serum retinyl ester maximum concentration (Tmax)
timeFrame: Baseline to 24 hours
Other outcomes:
measure: Total body vitamin A using retinol isotope dilution
timeFrame: Baseline
measure: Liver vitamin A concentrations using retinol isotope dilution
timeFrame: Baseline
measure: C-reactive protein
timeFrame: Baseline
measure: Serum carotenoids
timeFrame: Baseline
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Ndola
country: Zambia
facility: Tropical Diseases Research Centre
city: Rufunsa
country: Zambia
facility: Tropical Diseases Research Centre - Field Office
Study officials:
affiliation: University of Wisconsin, Madison
name: Sherry Tanumihardjo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Bryan M Gannon, PhD
role: STUDY_DIRECTOR
affiliation: University of Wisconsin, Madison
name: Luke M Funk, MD, MPH
role: STUDY_DIRECTOR
affiliation: Tropical Diseases Research Centre, Zambia
name: Justin Chileshe, PhD
role: STUDY_DIRECTOR
References: