Healthy VolunteersNCT06438562
Evaluation of Vitamin A Absorption From Fortified Bouillon
A study testing Unfortified bouillon plus vitamin A in oil, Bouillon fortified with vitamin A #1 plus unfortified oil and Bouillon fortified with vitamin A #2 plus unfortified oil in people with Healthy Volunteers and Vitamin A, run by University of Wisconsin, Madison at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Vitamin A
- What is being tested?
- Unfortified bouillon plus vitamin A in oil, Bouillon fortified with vitamin A #1 plus unfortified oil and Bouillon fortified with vitamin A #2 plus unfortified oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jul 2024to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers, Vitamin A
- Being tested
- Unfortified bouillon plus vitamin A in oil, Bouillon fortified with vitamin A #1 plus unfortified oil, Bouillon fortified with vitamin A #2 plus unfortified oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfortified bouillon plus vitamin A in oilOther
Participants consume unfortified bouillon with vitamin A oil
Bouillon fortified with vitamin A #1 plus unfortified oilOther
Participants consume vitamin A #1 fortified bouillon plus unfortified oil
Bouillon fortified with vitamin A #2 plus unfortified oilOther
Participants consume vitamin A #2 fortified bouillon plus unfortified oil
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A #1 | Experimental | Bouillon fortified with vitamin A formulation #1 plus unfortified oil Receives: Other: Bouillon fortified with vitamin A #1 plus unfortified oil |
| Vitamin A #2 | Experimental | Bouillon fortified with vitamin A formulation #2 plus unfortified oil Receives: Other: Bouillon fortified with vitamin A #2 plus unfortified oil |
| Unfortified bouillon positive control | Active comparator | Unfortified bouillon plus vitamin A fortified oil Receives: Other: Unfortified bouillon plus vitamin A in oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline to 24 hours
Secondary outcomes (4)
Serum retinol maximum concentration (Cmax)
Maximum serum retinol concentration observed, (µmol/L)
Measured: Baseline to 24 hours
Serum retinyl ester maximum concentration (Cmax)
Maximum serum retinyl ester concentration observed, (nmol/L)
Measured: Baseline to 24 hours
Time to maximum serum retinol concentration (Tmax)
Time to maximum serum retinol concentration, (h)
Measured: Baseline to 24 hours
Time to serum retinyl ester maximum concentration (Tmax)
Time to maximum serum retinyl ester concentration, (h)
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start10 Jul 2024
- Primary completion27 Nov 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive all 3 study treatments over 3 treatment periods.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Particles for Humanity, PBC, Tropical Diseases Research Centre, Zambia
- Responsible party
- Sponsor
- Investigators
- Sherry Tanumihardjo, PhD, Principal investigator, University of Wisconsin, MadisonBryan M Gannon, PhD, Study director, University of Wisconsin, MadisonLuke M Funk, MD, MPH, Study director, University of Wisconsin, MadisonJustin Chileshe, PhD, Study director, Tropical Diseases Research Centre, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438562
- Sponsor's protocol ID
- 2023-0327
- Other IDs
- A074600, CALS/NUTRITIONAL SCIENCES, Version 10/2/2024
- Status last verified
- Jan 2026
- First submitted
- 21 May 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06438562
- Acronym / sponsor ID
- 2023-0327
- Conditions
- Healthy Volunteers, Vitamin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Particles for Humanity, PBC, Tropical Diseases Research Centre, Zambia
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will receive all 3 study treatments over 3 treatment periods.
| Arm | Type | Receives |
|---|---|---|
| Vitamin A #1 | Experimental | Other: Bouillon fortified with vitamin A #1 plus unfortified oilBouillon fortified with vitamin A formulation #1 plus unfortified oil |
| Vitamin A #2 | Experimental | Other: Bouillon fortified with vitamin A #2 plus unfortified oilBouillon fortified with vitamin A formulation #2 plus unfortified oil |
| Unfortified bouillon positive control | Active comparator | Other: Unfortified bouillon plus vitamin A in oilUnfortified bouillon plus vitamin A fortified oil |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfortified bouillon plus vitamin A in oilParticipants consume unfortified bouillon with vitamin A oil | Other | Unfortified bouillon positive control |
| Bouillon fortified with vitamin A #1 plus unfortified oilParticipants consume vitamin A #1 fortified bouillon plus unfortified oil | Other | Vitamin A #1 |
| Bouillon fortified with vitamin A #2 plus unfortified oilParticipants consume vitamin A #2 fortified bouillon plus unfortified oil | Other | Vitamin A #2 |
Primary outcome
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)
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)
4 secondary outcomes
Serum retinol maximum concentration (Cmax)
Time frame: Baseline to 24 hours
Serum retinyl ester maximum concentration (Cmax)
Time frame: Baseline to 24 hours
Time to maximum serum retinol concentration (Tmax)
Time frame: Baseline to 24 hours
Time to serum retinyl ester maximum concentration (Tmax)
Time frame: Baseline to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Tanumihardjo, PhD principal investigator
University of Wisconsin, Madison
Bryan M Gannon, PhD study director
University of Wisconsin, Madison
Luke M Funk, MD, MPH study director
University of Wisconsin, Madison
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unfortified bouillon plus vitamin A in oil, Bouillon fortified with vitamin A #1 plus unfortified oil and Bouillon fortified with vitamin A #2 plus unfortified oil in people with Healthy Volunteers and Vitamin A, run by University of Wisconsin, Madison at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum retinyl ester area-under-the-effect-curve (time frame: Baseline to 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.