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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
58
Participants consume unfortified bouillon with vitamin A oil
Participants consume vitamin A #1 fortified bouillon plus unfortified oil
Participants consume vitamin A #2 fortified bouillon plus unfortified oil
University of Wisconsin-Madison
Madison, Wisconsin, United States
Tropical Diseases Research Centre - Field Office
Rufunsa, Zambia
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)
Time frame: 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)
Time frame: Baseline to 24 hours
Serum retinol maximum concentration (Cmax)
Maximum serum retinol concentration observed, (µmol/L)
Time frame: Baseline to 24 hours
Serum retinyl ester maximum concentration (Cmax)
Maximum serum retinyl ester concentration observed, (nmol/L)
Time frame: Baseline to 24 hours
Time to maximum serum retinol concentration (Tmax)
Time to maximum serum retinol concentration, (h)
Time frame: Baseline to 24 hours
Time to serum retinyl ester maximum concentration (Tmax)
Time to maximum serum retinyl ester concentration, (h)
Time frame: Baseline to 24 hours
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