Evaluation of Vitamin A Absorption From Fortified Bouillon

Not Applicable

Recruiting

• Conditions: Healthy Volunteers; Vitamin A

• Registration Number: NCT06438562
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-03
• Study Start: 2024-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serum retinyl ester area-under-the-effect-curve	Baseline to 24 hours	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)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

Tropical Diseases Research Centre; 🇿🇲 Ndola, Zambia

Tropical Diseases Research Centre - Field Office; 🇿🇲 Rufunsa, Zambia