Dietary ExposureNCT03562988

Bioequivalence Study on Vitamin C in Healthy Adults

A study testing Vitamin C gummy and Vitamin C tablet in people with Dietary Exposure, run by Church & Dwight Company, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Dietary Exposure
What is being tested?: Vitamin C gummy and Vitamin C tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2017to 22 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 35Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Church & Dwight Co., Inc.
Princeton, New Jersey, 08543

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Dietary Exposure
Being tested: Vitamin C gummy, Vitamin C tablet
Keywords: Measure Absorption of Vitamin C in Blood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin C gummyDietary supplement
vitamin C
Vitamin C tabletDietary supplement
vitamin C

Study groups in NCT03562988
Study group	Role	What they receive
Vitamin C gummy, Then Vitamin C Caplet	Other	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. Receives: Dietary Supplement: Vitamin C gummy; Dietary Supplement: Vitamin C tablet
Vitamin C tablet, Then Vitamin C gummy	Other	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. Receives: Dietary Supplement: Vitamin C gummy; Dietary Supplement: Vitamin C tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201722 Dec 2017

First posted20 Jun 2018
Study start1 Aug 2017
Primary completion22 Dec 2017
Study completion22 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dietary ExposureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03562988
Sponsor's protocol ID: ST-7666
Status last verified: Apr 2021
First submitted: 2 May 2018
Last updated: 23 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31747355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults
ClinicalTrials.gov ID: NCT03562988
Acronym / sponsor ID: ST-7666
Conditions: Dietary Exposure
Keywords: Measure Absorption of Vitamin C in Blood
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
Collaborators: KGK Science Inc.
Study start: 1 Aug 2017 (actual)
Primary completion: 22 Dec 2017 (actual)
Study completion: 22 Dec 2017 (actual)
First posted: 20 Jun 2018 (actual)
Results: Posted 23 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Vitamin C gummy, Then Vitamin C Caplet	Other	Dietary Supplement: Vitamin C gummy, Dietary Supplement: Vitamin C tabletThe 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	Other	Dietary Supplement: Vitamin C gummy, Dietary Supplement: Vitamin C tabletThe 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (35 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin C gummyvitamin C	Dietary supplement	Vitamin C gummy, Then Vitamin C Caplet, Vitamin C tablet, Then Vitamin C gummy
Vitamin C tabletvitamin C	Dietary supplement	Vitamin C gummy, Then Vitamin C Caplet, Vitamin C tablet, Then Vitamin C gummy

Primary outcome

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)]
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
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
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

2 secondary outcomes

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 Leucocyte Vitamin C Absorption Rate as Tmax
Time frame: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours

Results and safety

Results posted to the registry on 23 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin C Gummy, Then Vitamin C Caplet	17	15
Vitamin C Tablet, Then Vitamin C Gummy	18	15

Primary outcome: 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 (Standard Deviation). Unit: μmol*min/L

Measure	Vitamin C Gummy n = 32	Vitamin C Caplet n = 33
Value	1114.66 (236.81)	1149.09 (237.89)

Population analysed: Includes all Participants from treatment day 1, including those did not participate in treatment day 2.

Primary outcome: 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 (Standard Deviation). Unit: nmol*min/10^8 leukocytes

Measure	Vitamin C Gummy n = 32	Vitamin C Tablet n = 33
Value	273.20 (115.70)	297.20 (105.86)

Population analysed: Includes all Participants from treatment day 1, including those did not participate in treatment day 2.

Primary outcome: 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 (Standard Deviation). Unit: μmol/L

Measure	Vitamin C Gummy n = 32	Vitamin C Tablet n = 33
Value	72.75 (15.74)	78.97 (20.51)

Population analysed: Includes all Participants from treatment day 1, including that those did not participate in treatment day 2.

Primary outcome: 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 (Standard Deviation). Unit: nmol/10^8 leukocytes

Measure	Vitamin C Gummy n = 32	Vitamin C Tablet n = 33
Value	22.96 (18.91)	22.74 (13.98)

Population analysed: Includes all Participants from treatment day 1, including those did not participate in treatment day 2.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants entered any AE's in a daily diary from the initiation of the study until 24 hours after the last oral dosing. Additionally, participants were asked about AE's at each visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin C Gummy	0 of 35 (0%)	2 of 32 (6.3%)	0 of 35
Vitamin C Tablet	0 of 35 (0%)	1 of 33 (3%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31747355Evans 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annahita Ghassemi study director

Church & Dwight Company, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin C gummy and Vitamin C tablet in people with Dietary Exposure, run by Church & Dwight Company, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.