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Completed

NCT Number: NCT06438562

Evaluation of Vitamin A Absorption From Fortified Bouillon

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfortified bouillon plus vitamin A in oil

Other

Participants consume unfortified bouillon with vitamin A oil

Bouillon fortified with vitamin A #1 plus unfortified oil

Other

Participants consume vitamin A #1 fortified bouillon plus unfortified oil

Bouillon fortified with vitamin A #2 plus unfortified oil

Other

Participants consume vitamin A #2 fortified bouillon plus unfortified oil

Primary outcomes

  1. Serum retinyl ester area-under-the-effect-curve

    Time frame: Baseline to 8 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)

  2. Serum retinyl ester area-under-the-effect-curve

    Time frame: 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 outcomes

  1. Serum retinol maximum concentration (Cmax)

    Time frame: Baseline to 24 hours

    Maximum serum retinol concentration observed, (µmol/L)

  2. Serum retinyl ester maximum concentration (Cmax)

    Time frame: Baseline to 24 hours

    Maximum serum retinyl ester concentration observed, (nmol/L)

  3. Time to maximum serum retinol concentration (Tmax)

    Time frame: Baseline to 24 hours

    Time to maximum serum retinol concentration, (h)

  4. Time to serum retinyl ester maximum concentration (Tmax)

    Time frame: Baseline to 24 hours

    Time to maximum serum retinyl ester concentration, (h)

Other outcomes

  1. Total body vitamin A using retinol isotope dilution

    Time frame: Baseline

    The retinol isotope dilution test provides an estimate of total body stores of vitamin A, (umol)

  2. Liver vitamin A concentrations using retinol isotope dilution

    Time frame: Baseline

    The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g)

  3. C-reactive protein

    Time frame: Baseline

    To determine inflammation at each treatment visit, (mg/L)

  4. Serum carotenoids

    Time frame: Baseline

    Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Particles for Humanity, PBC
  • Tropical Diseases Research Centre, Zambia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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