Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults
Not Applicable
Completed
- Conditions
- Bioequivalence of Vitamin D in Healthy Adults
- Interventions
- Dietary Supplement: vitamin D3
- Registration Number
- NCT03552666
- Lead Sponsor
- Church & Dwight Company, Inc.
- Brief Summary
The objective of this clinical 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 oral dose of vitamin D3 as gummy and tablet supplementation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Females not of childbearing potential (i.e., hysterectomy, oophorectomy, bilateral tubal ligation or postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control such as 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 (urine 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 human immunodeficiency virus (HIV)
- Individuals who have planned surgery during the course of the trial
- 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 healthy 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 individuals 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Vitafusion Extra Strength Vitamin D3 Gummy vitamin D3 A single oral dose of gummy vitamin D3 to monitor Vitamin D blood levels Nature Made Vitamin D3 Tablet vitamin D3 A single oral dose of tablet vitamin D3 to monitor Vitamin D blood levels
- Primary Outcome Measures
Name Time Method Mean Absorption baseline, 3, 6, 10, 24 and 48 hours A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)
- Secondary Outcome Measures
Name Time Method Absorption Rate 0 to 48 hours A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)
Trial Locations
- Locations (1)
Church & Dwight Co., Inc.
🇺🇸Princeton, New Jersey, United States