Bioequivalence Study on Vitamin C in Healthy Adults

A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03562988

Enrollment

Registered

2018-06-20

Start date

2017-08-01

Completion date

2017-12-22

Last updated

2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Exposure

Keywords

Measure Absorption of Vitamin C in Blood

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.

Interventions

DIETARY_SUPPLEMENTVitamin C gummy

vitamin C

DIETARY_SUPPLEMENTVitamin C tablet

vitamin C

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 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 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

Measure	Time frame	Description
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
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

Countries

United States

Participant flow

Pre-assignment details

Cross over study. Participants received each treatment at one of the two treatment visits.

Participants by arm

Arm	Count
All Study Participants All Study Participants	35
Total	35

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Sex: Female, Male Female	24 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 35
other Total, other adverse events	2 / 32	1 / 33
serious Total, serious adverse events	0 / 35	0 / 35