Phase
Condition
Healthy Volunteers
Treatment
Unfortified bouillon plus vitamin A in oil
Bouillon fortified with vitamin A #1 plus unfortified oil
Bouillon fortified with vitamin A #2 plus unfortified oil
Clinical Study ID
Ages 18-49 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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, abaseline hemoglobin and pregnancy test, adherence to a low-vitamin A diet atspecified times throughout the study, consumption of provided meals (specifically, abreakfast of bouillon, peanut butter, and a bagel or bread), and, except for theScreening visit, foregoing alcohol for at least 2 days before each visit and fastingfor ≥8 hours before each visit
Exclusion
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'sdisease, 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 Aand 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 samplecollection
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
Study Design
Study Description
Connect with a study center
University of Wisconsin-Madison
Madison, Wisconsin 53706
United StatesActive - Recruiting
Tropical Diseases Research Centre
Ndola,
ZambiaSite Not Available
Tropical Diseases Research Centre - Field Office
Rufunsa,
ZambiaSite Not Available
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