Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

Completed · Not applicable

Conditions studied: Bioequivalence of Vitamin D in Healthy Adults

In brief

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.

Key facts

Study ID

NCT03552666

Run by

Church & Dwight Company, Inc.

People needed

9

Starts

2016-12-26

Expected to finish

2017-03-27

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Church & Dwight Co., Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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