Princeton, New Jersey 08543

  • Measure Absorption of Vitamin D in Blood

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03552653


Primary Contact:

Study Director
Annahita Ghassemi
Church & Dwight Company, Inc.


Backup Contact:

N/A


Location Contact:

Princeton, New Jersey 08543
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 17, 2021

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