Bioequivalence Study on Vitamin D in Healthy Adults

NCT ID: NCT03552653

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-26
• Study Completion Date: 2017-12-22

Brief Summary

The objective of this 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.

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 dose of gummy and tablet supplementation.

Conditions

Measure Absorption of Vitamin D in Blood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Vitafusion Extra Strength Vitamin D3 Gummy

Single oral dose of gummy vitamin D3 to monitor vitamin D blood levels

Group Type: EXPERIMENTAL

Vitafusion Extra Strength Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Monitor Vitamin D blood levels

Nature Made Vitamin D3 Tablet

Single oral dose of tablet vitamin D3 to monitor vitamin D blood levels

Group Type: ACTIVE_COMPARATOR

Vitafusion Extra Strength Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Monitor Vitamin D blood levels

Interventions

Vitafusion Extra Strength Vitamin D

Monitor Vitamin D blood levels

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Nature Made Vitamin D

Eligibility Criteria

Inclusion Criteria

• Female participants not of childbearing potential (hysterectomy, oophorectomy, bilateral tubal ligation, postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control including 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 (uterine 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 HIV (human immunodeficiency virus)
• 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 health 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 individual 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annahita Ghassemi

Role: STUDY_DIRECTOR

Church & Dwight Company, Inc.

Locations

Church & Dwight Co., Inc.

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

ST-7639N31

Identifier Type: -

Identifier Source: org_study_id