Unfortified bouillon plus vitamin A in oil
OtherParticipants consume unfortified bouillon with vitamin A oil
NCT Number: NCT06438562
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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Notify Me18 year–49 year
Female
Interventional
Not applicable
University of Wisconsin-Madison, Madison, Wisconsin, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
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)
Time frame: Baseline to 24 hours
Maximum serum retinol concentration observed, (µmol/L)
Time frame: Baseline to 24 hours
Maximum serum retinyl ester concentration observed, (nmol/L)
Time frame: Baseline to 24 hours
Time to maximum serum retinol concentration, (h)
Time frame: Baseline to 24 hours
Time to maximum serum retinyl ester concentration, (h)
Time frame: Baseline
The retinol isotope dilution test provides an estimate of total body stores of vitamin A, (umol)
Time frame: Baseline
The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g)
Time frame: Baseline
To determine inflammation at each treatment visit, (mg/L)
Time frame: Baseline
Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L)
University of Wisconsin, Madison
Other
Evaluation of Vitamin A Absorption From Fortified Bouillon Using Post-prandial Retinyl Ester Response in Comparison With an Oil-based Vitamin A Supplement
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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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