Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

NCT03552666 | Completed

• 1 other identifier: ST-7639N9
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioequivalence of Vitamin D in Healthy Adults

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

• Mean Absorption

  A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)

  baseline, 3, 6, 10, 24 and 48 hours

Secondary Outcomes (1)

• Absorption Rate

  0 to 48 hours

Study Arms (2)

Vitafusion Extra Strength Vitamin D3 Gummy

EXPERIMENTAL

A single oral dose of gummy vitamin D3 to monitor Vitamin D blood levels

Dietary Supplement: vitamin D3

Nature Made Vitamin D3 Tablet

ACTIVE COMPARATOR

A single oral dose of tablet vitamin D3 to monitor Vitamin D blood levels

Dietary Supplement: vitamin D3

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Nature Made Vitamin D3 Tablet; Vitafusion Extra Strength Vitamin D3 Gummy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Church & Dwight Co., Inc.

Princeton, New Jersey, 08543, United States

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, examiner-blind, comparator-controlled crossover study

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 12, 2018
• Study Start: December 26, 2016
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)