Evaluation of Vitamin A Absorption From Fortified Bouillon

NCT06438562 | Completed

• 4 other identifiers: 2023-0327A074600CALS/NUTRITIONAL SCIENCESVersion 10/2/2024
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy Volunteers; Vitamin A

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum retinol maximum concentration (Cmax)

  Baseline to 24 hours

• Serum retinyl ester maximum concentration (Cmax)

  Baseline to 24 hours

• Time to maximum serum retinol concentration (Tmax)

  Baseline to 24 hours

• Time to serum retinyl ester maximum concentration (Tmax)

  Baseline to 24 hours

Other Outcomes (4)

• Total body vitamin A using retinol isotope dilution

  Baseline

• Liver vitamin A concentrations using retinol isotope dilution

  Baseline

• C-reactive protein

  Baseline

Study Arms (3)

Vitamin A #1

EXPERIMENTAL

Bouillon fortified with vitamin A formulation #1 plus unfortified oil

Other: Bouillon fortified with vitamin A #1 plus unfortified oil

Vitamin A #2

EXPERIMENTAL

Bouillon fortified with vitamin A formulation #2 plus unfortified oil

Other: Bouillon fortified with vitamin A #2 plus unfortified oil

Unfortified bouillon positive control

ACTIVE COMPARATOR

Unfortified bouillon plus vitamin A fortified oil

Other: Unfortified bouillon plus vitamin A in oil

Interventions

Unfortified bouillon plus vitamin A in oil OTHER

Participants consume unfortified bouillon with vitamin A oil

Unfortified bouillon positive control

Bouillon fortified with vitamin A #1 plus unfortified oil OTHER

Participants consume vitamin A #1 fortified bouillon plus unfortified oil

Vitamin A #1

Bouillon fortified with vitamin A #2 plus unfortified oil OTHER

Participants consume vitamin A #2 fortified bouillon plus unfortified oil

Vitamin A #2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tropical Diseases Research Centre, Zambia: collaborator
• University of Wisconsin, Madison: lead
• Particles for Humanity, PBC: collaborator

Study Sites (2)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Tropical Diseases Research Centre - Field Office

Rufunsa, Zambia

Location

MeSH Terms

Interventions

Vitamin A; Oils

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Lipids

Study Officials

• Sherry Tanumihardjo, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized and blinded to all treatments and treatment sequence. Care providers and investigators are blinded to experimental treatments and treatment sequence. Outcome assessors are blinded to all treatments and treatment sequence.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive all 3 study treatments over 3 treatment periods.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 3, 2024
• Study Start: July 10, 2024
• Primary Completion: November 27, 2025
• Study Completion: December 8, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); US (1)