Bioequivalence Study on Vitamin C in Healthy Adults

Not Applicable

Completed

Conditions: Dietary Exposure

Interventions: Dietary Supplement: Vitamin C gummy
Dietary Supplement: Vitamin C tablet

Registration Number: NCT03562988

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin C gummy, Then Vitamin C Caplet	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 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 tablet, Then Vitamin C gummy	Vitamin C tablet	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 gummy, Then Vitamin C Caplet	Vitamin C tablet	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 tablet, Then Vitamin C gummy	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.

Primary Outcome Measures

Name	Time	Method
Mean Plasma L-ascorbic Acid as Cmax	baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours	Mean Plasma L-ascorbic Acid as Cmax
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 Plasma L-ascorbic Acid as Total Area Under the Curve \[AUC(0-24 hours)\]
Mean Leukocyte 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 \[AUC(0-24 hours)\] for All Study Participants
Mean Leukocyte 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

Secondary Outcome Measures

Name	Time	Method
Mean Leucocyte Vitamin C Absorption Rate as Tmax	baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours	Mean Time of maximum Vitamin C concentration
Mean Plasma Vitamin C Absorption Rate as Tmax	baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours	Mean Time of maximum Vitamin C concentration