Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

Church & Dwight

Status

Completed

Conditions

Bioequivalence of Vitamin D in Healthy Adults

Treatments

Dietary Supplement: vitamin D3

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03552666

ST-7639N9

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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