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Bioequivalence Study on Vitamin C 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: NCT03562988
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Church & Dwight Company, Inc.

Brief Summary:
The objective of this exploratory pharmacokinetic research study is to demonstrate that both caplets and gummies provide an effective dose of ascorbic acid in healthy adults.

Condition or disease Intervention/treatment Phase
Bioequivalence of Vitamin C in Healthy Adults Dietary Supplement: Vitafusion Power C gummy Dietary Supplement: Nature Made vitamin C tablet Not Applicable

Detailed Description:
This randomized, examiner-blind, cross-over study evaluates the bioequivalence of a gummy containing vitamin C relative to a caplet comparator product in healthy adults.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: vitafusion Power C gummy
A single oral dose of gummy vitamin C to monitor vitamin C blood levels
Dietary Supplement: Vitafusion Power C gummy
vitamin C
Other Name: vitamin C gummy

Active Comparator: Nature Made vitamin C caplet
A single oral dose of gummy vitamin C to monitor vitamin C blood levels
Dietary Supplement: Nature Made vitamin C tablet
vitamin C
Other Name: vitamin C tablet




Primary Outcome Measures :
  1. Mean Absorption [ Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours ]
    A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)


Secondary Outcome Measures :
  1. Absorption Rate [ Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18.5 to 29.9 kg/m2 (+/- 1 kg/m2)
  • Healthy as determined by laboratory results and medical history
  • Maintains current level of physical activity throughout duration of study
  • Does not donate blood for the next 3 months after completing study
  • Avoidance of foods and beverages fortified with vitamin C for at least 7 days prior to enrollment and duration of study
  • Avoidance of citrus foods, citrus juices, and tomato juice for at least 7 days prior to enrollment and duration of study
  • Non smoker or ex-smoker > 1 year
  • Has given voluntary, written informed consent to participate in study
  • Agrees to avoid high caffeine and alcohol intake 72 hours prior to in-clinic test days and during the 24-hour in-clinic test days
  • Females not of child bearing potential, defined as having had a hysterectomy, oophorectomy, bilateral tubal ligation or are post-menopausal
  • Females of child bearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods include hormonal contraceptives, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner

Exclusion Criteria:

  • Women who are pregnant, breast feeding, or planning to become pregnant during the trial
  • Duodenal or gastric ulcer, gastritis, hiatus hernia, or GERD within past 3 months
  • History of irritable bowel syndrome and related disorders
  • Significant gastrointestinal disease (includes but not limited to Celiac disease)
  • History of malabsorption
  • Unstable medical conditions as determined by the Qualified Investigator
  • Blood pressure greater than 150/90 mmHg
  • Cancer except skin cancers completely excised with no chemotherapy or radiation following and with a negative follow up. (Volunteers with cancer in full remission for more than 4 years after diagnosis are acceptable)
  • Clinically significant abnormal laboratory results at screening
  • Metabolic disease or chronic diseases (ex/ hyperlipidemia, hypertension, hypercholesterolemia)
  • Type I or Type II diabetes
  • History of kidney stones
  • Use of prescription or over the counter products known to interact with vitamin C within 72 hours of enrollment and duration of 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
  • Use of tobacco products within the last year
  • More than 2 alcoholic drinks per day
  • Drug abuse within 1 year of enrollment
  • Use of medicinal marijuana
  • Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with HIV
  • Individuals who have planned surgery during the course of the trial
  • St. John's wort in the last 30 days prior to enrollment and duration of study
  • Use of vitamin C, multivitamins containing vitamin C, or foods or beverages fortified with vitamin C and other natural healthy products containing vitamin C within 7 days of enrollment and duration of study
  • Consumption of citrus foods, citrus juices, and tomato juice with 7 days of enrollment and duration of study
  • Use of anticoagulants, barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
  • Use of natural health products/dietary supplements with 7 days of enrollment or duration of study
  • Current diagnosis and history of blood/bleeding disorders
  • Current diagnosis and history of anemia of any etiology defined as hemoglobin < 145 g/L for males and < 123 g/L for females
  • History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
  • History of hemochromatosis
  • Blood donation in the past 3 months
  • Individuals who plan to donate blood during the study or within 30 days of completing the study
  • Participation in a clinical research trial within 30 days prior to enrollment
  • Allergy or sensitivity to supplement ingredients or to any food or beverage provided during the study
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Qualified Investigator's opinion nay adversely affect an individual's ability to complete the study or its measures or which may pose significant risk to the individual

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): NCT03562988


Locations
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United States, New Jersey
Church & Dwight Co., Inc.
Princeton, New Jersey, United States, 08543
Sponsors and Collaborators
Church & Dwight Company, Inc.
KGK Science Inc.
Investigators
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Study Director: Annahita Ghassemi Church & Dwight Company, Inc.

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Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT03562988     History of Changes
Other Study ID Numbers: ST-7666
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents