Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence of Vitamin D in Healthy Adults
• Intervention / Treatment: Dietary supplement: vitamin D3

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08543
      • Church & Dwight Co., Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitafusion Extra Strength Vitamin D3 Gummy; A single oral dose of gummy vitamin D3 to monitor Vitamin D blood levels	Dietary supplement: vitamin D3
Active Comparator: Nature Made Vitamin D3 Tablet; A single oral dose of tablet vitamin D3 to monitor Vitamin D blood levels	Dietary supplement: vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absorption	A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)	baseline, 3, 6, 10, 24 and 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption Rate	A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)	0 to 48 hours

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.
• Collaborators: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2016
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): March 27, 2017

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ST-7639N9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No