Measure Absorption of Vitamin D in Blood
Conditions
Brief summary
The objective of this study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
Detailed description
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same dose of gummy and tablet supplementation.
Interventions
DIETARY_SUPPLEMENTVitafusion Extra Strength Vitamin D
Monitor Vitamin D blood levels
Sponsors
Medical University of South Carolina
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention model description
Randomized, cross-over, comparator-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants not of childbearing potential (hysterectomy, oophorectomy, bilateral tubal ligation, postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control including hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner * BMI 18.5 to 29.9 kg/m2 * Agrees to maintain current level of physical activity throughout the study * Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)
Exclusion criteria
* Women who are pregnant to be determined by UPT (uterine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study * Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months * Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders * Unstable medical conditions as determined by the principal investigator * Clinically significant abnormal laboratory results on CBC or BMP at screening * Cancer chemotherapy/radiation treatment within the 3 months prior to enrollment * Metabolic disease * History of kidney stones * Use of prescription or over the counter products known to interact with vitamin D within 72 hours of randomization and during the trial such as aspirin and NSAIDs, aluminum, iron and proton pump inhibitors * Use of acute over the counter medication within 72 hours of test product dosing * Smokers * Consumption of more than 2 alcoholic drinks per day * Drug abuse within the past year * Use of medicinal marijuana * Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with HIV (human immunodeficiency virus) * Use of St. John's wort in the last 30 days before randomization and during the study * Use of vitamin D, multivitamins containing vitamin D, foods or beverages fortified with vitamin D and other natural health products containing vitamin D, or consumption of grapefruit/ grapefruit juice within 14 days of randomization and during the study * Use of anticoagulants, barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications * History of blood/bleeding disorders * Anemia of any etiology defined as hemoglobin \< 140 g/L for males and \< 123 g/L for females * Blood donation in the past 3 months, or individual planning to donate blood during the study or within 30 days of completion of study * Participation in a clinical research trial within 30 days prior to randomization * Allergy or sensitivity to any ingredient in supplements provided during the study * Individuals who are cognitively impaired and/or who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absorption | baseline, 3, 6, 10, 24 and 48 hours | A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absorption Rate | 0 to 48 hours | A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet) |
Countries
United States
Outcome results
None listed