Evaluation of Vitamin A Absorption From Fortified Bouillon

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438562
• Other study ID #: 2023-0327
• Secondary ID: A074600CALS/NUTR
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Bryan Gannon, PhD
• Phone: 608-265-2026
• Email: bgannon[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy, nonpregnant women

• =18 and <49 years of age

• Able and willing to provide informed consent

• Body mass index (BMI) between 20 to 30 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

Related Conditions & MeSH terms

• Healthy Volunteers
• Vitamin A

Intervention

Dietary Supplement:
• Unfortified bouillon plus vitamin A in oil
Participants consume unfortified bouillon with vitamin A oil
• Bouillon fortified with vitamin A #1 plus unfortified oil
Participants consume vitamin A #1 fortified bouillon plus unfortified oil
• Bouillon fortified with vitamin A #2 plus unfortified oil
Participants consume vitamin A #2 fortified bouillon plus unfortified oil

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin
Zambia	Tropical Diseases Research Centre	Ndola
Zambia	Tropical Diseases Research Centre - Field Office	Rufunsa

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Particles for Humanity, PBC, Tropical Diseases Research Centre, Zambia

Countries where clinical trial is conducted

United States,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Liver vitamin A concentrations using retinol isotope dilution	The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g)	Baseline
Other	C-reactive protein	To determine inflammation at each treatment visit, (mg/L)	Baseline
Other	Serum carotenoids	Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L)	Baseline
Primary	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
Primary	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	Serum retinol maximum concentration (Cmax)	Maximum serum retinol concentration observed, (µmol/L)	Baseline to 24 hours
Secondary	Serum retinyl ester maximum concentration (Cmax)	Maximum serum retinyl ester concentration observed, (nmol/L)	Baseline to 24 hours
Secondary	Time to maximum serum retinol concentration (Tmax)	Time to maximum serum retinol concentration, (h)	Baseline to 24 hours
Secondary	Time to serum retinyl ester maximum concentration (Tmax)	Time to maximum serum retinyl ester concentration, (h)	Baseline to 24 hours