Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

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