Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

Bioequivalence of Vitamin D in Healthy Adults Clinical Trial

Official title:

A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552666
• Other study ID #: ST-7639N9
• Status: Completed
• Phase: N/A
• Start date: December 26, 2016
• Est. completion date: March 27, 2017

Study information

• Verified date: June 2018
• Source: Church & Dwight Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 27, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence of Vitamin D in Healthy Adults

Intervention

Dietary Supplement:
• vitamin D3

Locations

Country	Name	City	State
United States	Church & Dwight Co., Inc.	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Absorption	A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)	baseline, 3, 6, 10, 24 and 48 hours
Secondary	Absorption Rate	A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)	0 to 48 hours