- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562988
Bioequivalence Study on Vitamin C in Healthy Adults
July 27, 2021 updated by: Church & Dwight Company, Inc.
A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08543
- Church & Dwight Co., Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Vitamin C gummy, Then Vitamin C Caplet
The study consisted of two single-day study periods separated by a 7-day washout.
At the first study day, a single oral dose of vitamin C gummy (1007.2mg)
was orally administered following a 12 hour fasting period.
After a 7 day washout period, a single oral dose of vitamin C caplet (1027.9mg)
was orally administered following a 12 hour fasting period.
|
vitamin C
vitamin C
|
OTHER: Vitamin C tablet, Then Vitamin C gummy
The study consisted of two single-day study periods separated by a 7-day washout.
At the first study day, a single oral dose of vitamin C caplet (1027.9mg)
was orally administered following a 12 hour fasting period.
After a 7 day washout period, a single oral dose of vitamin C gummy (1007.2mg)
was orally administered following a 12 hour fasting period.
|
vitamin C
vitamin C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)]
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] for All Study Participants
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Plasma L-ascorbic Acid as Cmax
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Plasma L-ascorbic Acid as Cmax
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Leukocyte L-ascorbic Acid as Cmax
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Leukocyte L-ascorbic Acid as Cmax
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Plasma Vitamin C Absorption Rate as Tmax
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Time of maximum Vitamin C concentration
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Leucocyte Vitamin C Absorption Rate as Tmax
Time Frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Mean Time of maximum Vitamin C concentration
|
baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ACTUAL)
December 22, 2017
Study Completion (ACTUAL)
December 22, 2017
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (ACTUAL)
June 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 23, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-7666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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