Evaluation of Vitamin A Absorption 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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Vitamin A
• Intervention / Treatment: Other: Bouillon fortified with vitamin A #1 plus unfortified oil; Other: Bouillon fortified with vitamin A #2 plus unfortified oil; Other: Unfortified bouillon plus vitamin A in oil

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin-Madison
• Zambia
  • Rufunsa, Zambia
    • Tropical Diseases Research Centre - Field Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin A #1; Bouillon fortified with vitamin A formulation #1 plus unfortified oil	Other: Bouillon fortified with vitamin A #1 plus unfortified oil; Participants consume vitamin A #1 fortified bouillon plus unfortified oil
Experimental: Vitamin A #2; Bouillon fortified with vitamin A formulation #2 plus unfortified oil	Other: Bouillon fortified with vitamin A #2 plus unfortified oil; Participants consume vitamin A #2 fortified bouillon plus unfortified oil
Active Comparator: Unfortified bouillon positive control; Unfortified bouillon plus vitamin A fortified oil	Other: Unfortified bouillon plus vitamin A in oil; Participants consume unfortified bouillon with vitamin A oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum retinyl ester area-under-the-effect-curve	The serum retinyl ester area-under-the-effect-curve (corrected for baseline retinyl ester concentrations) will be calculated for each treatment to determine relative absorption of vitamin A, (nmol/L*h)	Baseline to 8 hours
Serum retinyl ester area-under-the-effect-curve	The serum retinyl ester area-under-the-effect-curve (corrected for baseline retinyl ester concentrations) will be calculated for each treatment to determine relative absorption of vitamin A, (nmol/L*h)	Baseline to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum retinol maximum concentration (Cmax)	Maximum serum retinol concentration observed, (µmol/L)	Baseline to 24 hours
Serum retinyl ester maximum concentration (Cmax)	Maximum serum retinyl ester concentration observed, (nmol/L)	Baseline to 24 hours
Time to maximum serum retinol concentration (Tmax)	Time to maximum serum retinol concentration, (h)	Baseline to 24 hours
Time to serum retinyl ester maximum concentration (Tmax)	Time to maximum serum retinyl ester concentration, (h)	Baseline to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body vitamin A using retinol isotope dilution	The retinol isotope dilution test provides an estimate of total body stores of vitamin A, (umol)	Baseline
Liver vitamin A concentrations using retinol isotope dilution	The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g)	Baseline
C-reactive protein	To determine inflammation at each treatment visit, (mg/L)	Baseline
Serum carotenoids	Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L)	Baseline

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Tropical Diseases Research Centre, Zambia; Particles for Humanity, PBC
• Investigators: Principal Investigator: Sherry Tanumihardjo, PhD, University of Wisconsin, Madison; Study Director: Bryan M Gannon, PhD, University of Wisconsin, Madison; Study Director: Luke M Funk, MD, MPH, University of Wisconsin, Madison; Study Director: Justin Chileshe, PhD, Tropical Diseases Research Centre, Zambia

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): November 27, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Lipids; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Diterpenes; Vitamin A; Oils
• Other Study ID Numbers: 2023-0327; A074600 (Other Identifier: UW- Madison); CALS/NUTRITIONAL SCIENCES (Other Identifier: UW- Madison); Version 10/2/2024 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No