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. 2019 May 7;11(5):1023. doi: 10.3390/nu11051023

Table 1.

Inclusion and exclusion criteria.

Inclusion Criteria
  • Ages 18–45 years

  • Sexes: males and females

  • 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, or non-heterosexual lifestyle or agree to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner

  • BMI 18.5 to 29.9 kg/m2

  • Agree to maintain current level of physical activity throughout the study

  • Agree to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 h 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 h 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 h 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 < 14.0 mg/dL for males and < 12.3 mg/dL 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