Healthy Volunteers, Vitamin A
Conditions
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.
Detailed 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.
Interventions
OTHERUnfortified bouillon plus vitamin A in oil
Participants consume unfortified bouillon with vitamin A oil
OTHERBouillon fortified with vitamin A #1 plus unfortified oil
Participants consume vitamin A #1 fortified bouillon plus unfortified oil
OTHERBouillon fortified with vitamin A #2 plus unfortified oil
Participants consume vitamin A #2 fortified bouillon plus unfortified oil
Sponsors
Particles for Humanity, PBC
Tropical Diseases Research Centre, Zambia
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will receive all 3 study treatments over 3 treatment periods.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum retinyl ester area-under-the-effect-curve | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum retinol maximum concentration (Cmax) | Baseline to 24 hours | Maximum serum retinol concentration observed, (µmol/L) |
| Serum retinyl ester maximum concentration (Cmax) | Baseline to 24 hours | Maximum serum retinyl ester concentration observed, (nmol/L) |
| Time to maximum serum retinol concentration (Tmax) | Baseline to 24 hours | Time to maximum serum retinol concentration, (h) |
| Time to serum retinyl ester maximum concentration (Tmax) | Baseline to 24 hours | Time to maximum serum retinyl ester concentration, (h) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liver vitamin A concentrations using retinol isotope dilution | Baseline | The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g) |
| C-reactive protein | Baseline | To determine inflammation at each treatment visit, (mg/L) |
| Serum carotenoids | Baseline | Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L) |
| Total body vitamin A using retinol isotope dilution | Baseline | The retinol isotope dilution test provides an estimate of total body stores of vitamin A, (umol) |
Countries
United States, Zambia
Outcome results
None listed