Clinical trial NCT03552653: Bioequivalence Study on Vitamin D in Healthy Adults
Official title: A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measure Absorption of Vitamin D in Blood
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2018-06-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over, comparator-controlled
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Absorption
timeFrame: baseline, 3, 6, 10, 24 and 48 hours
Secondary outcomes:
measure: Absorption Rate
timeFrame: 0 to 48 hours
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Church & Dwight Co., Inc.
state: New Jersey
Study officials:
affiliation: Church & Dwight Company, Inc.
name: Annahita Ghassemi
role: STUDY_DIRECTOR
References: