Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552666
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Church & Dwight Company, Inc.

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.

Condition or disease Intervention/treatment Phase
Bioequivalence of Vitamin D in Healthy Adults Dietary Supplement: vitamin D3 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, examiner-blind, comparator-controlled crossover study
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
Actual Study Start Date : December 26, 2016
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : March 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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



Primary Outcome Measures :
  1. Mean Absorption [ Time Frame: baseline, 3, 6, 10, 24 and 48 hours ]
    A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)


Secondary Outcome Measures :
  1. Absorption Rate [ Time Frame: 0 to 48 hours ]
    A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552666


Locations
Layout table for location information
United States, New Jersey
Church & Dwight Co., Inc.
Princeton, New Jersey, United States, 08543
Sponsors and Collaborators
Church & Dwight Company, Inc.
Medical University of South Carolina

Layout table for additonal information
Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT03552666     History of Changes
Other Study ID Numbers: ST-7639N9
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Church & Dwight Company, Inc.:
Vitamin D
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents