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| ID | Type | Description | Link |
|---|---|---|---|
| A074600 | Other Identifier | UW- Madison | |
| CALS/NUTRITIONAL SCIENCES | Other Identifier | UW- Madison | |
| Version 10/2/2024 | Other Identifier | UW- Madison |
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| Name | Class |
|---|---|
| Particles for Humanity, PBC | INDUSTRY |
| Tropical Diseases Research Centre, Zambia | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin A #1 | Experimental | Bouillon fortified with vitamin A formulation #1 plus unfortified oil |
|
| Vitamin A #2 | Experimental | Bouillon fortified with vitamin A formulation #2 plus unfortified oil |
|
| Unfortified bouillon positive control | Active Comparator | Unfortified bouillon plus vitamin A fortified oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfortified bouillon plus vitamin A in oil | Other | Participants consume unfortified bouillon with vitamin A oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum retinol maximum concentration (Cmax) | Maximum serum retinol concentration observed, (µmol/L) | Baseline to 24 hours |
| Serum retinyl ester maximum concentration (Cmax) | Maximum serum retinyl ester concentration observed, (nmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Liver vitamin A concentrations using retinol isotope dilution |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53706 | United States | ||
| Tropical Diseases Research Centre - Field Office |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D009821 | Oils |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Participants will receive all 3 study treatments over 3 treatment periods.
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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.
| Bouillon fortified with vitamin A #1 plus unfortified oil | Other | Participants consume vitamin A #1 fortified bouillon plus unfortified oil |
|
| Bouillon fortified with vitamin A #2 plus unfortified oil | Other | Participants consume vitamin A #2 fortified bouillon plus unfortified oil |
|
| Baseline to 24 hours |
| Time to maximum serum retinol concentration (Tmax) | Time to maximum serum retinol concentration, (h) | Baseline to 24 hours |
| Time to serum retinyl ester maximum concentration (Tmax) | Time to maximum serum retinyl ester concentration, (h) | Baseline to 24 hours |
The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g)
| Baseline |
| C-reactive protein | To determine inflammation at each treatment visit, (mg/L) | Baseline |
| Serum carotenoids | Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L) | Baseline |
| Rufunsa |
| Zambia |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D008055 | Lipids |