Clinical trial NCT03562988: Bioequivalence Study on Vitamin C in Healthy Adults
Official title: A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Keywords: Measure Absorption of Vitamin C in Blood
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2018-06-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
measure: Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
measure: Mean Plasma L-ascorbic Acid as Cmax
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
measure: Mean Leukocyte L-ascorbic Acid as Cmax
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Secondary outcomes:
measure: Mean Plasma Vitamin C Absorption Rate as Tmax
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
measure: Mean Leucocyte Vitamin C Absorption Rate as Tmax
timeFrame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Church & Dwight Co., Inc.
state: New Jersey
Study officials:
affiliation: Church & Dwight Company, Inc.
name: Annahita Ghassemi
role: STUDY_DIRECTOR
References:
citation: Evans M, Guthrie N, Zhang HK, Hooper W, Wong A, Ghassemi A. Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial. J Am Coll Nutr. 2020 Jul;39(5):422-431. doi: 10.1080/07315724.2019.1684398. Epub 2019 Nov 20.