Bioequivalence Study on Vitamin D in Healthy Adults

Overview

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.

Full Title of Study: “A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 22, 2017

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.

Interventions

  • Dietary Supplement: Vitafusion Extra Strength Vitamin D
    • Monitor Vitamin D blood levels

Arms, Groups and Cohorts

  • Experimental: Vitafusion Extra Strength Vitamin D3 Gummy
    • Single oral dose of gummy vitamin D3 to monitor vitamin D blood levels
  • Active Comparator: Nature Made Vitamin D3 Tablet
    • Single oral dose of tablet vitamin D3 to monitor vitamin D blood levels

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Church & Dwight Company, Inc.
  • Collaborator
    • Medical University of South Carolina
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Annahita Ghassemi, Study Director, Church & Dwight Company, Inc.

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