Bioequivalence Study on Vitamin C in Healthy Adults

NCT03562988 | Completed Results

• 1 other identifier: ST-7666
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Exposure

Keywords

Measure Absorption of Vitamin C in Blood

Outcome Measures

Primary Outcomes (4)

• 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 \[AUC(0-24 hours)\]

  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

  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

  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

  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

  baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours

• Mean Leucocyte Vitamin C Absorption Rate as Tmax

  baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours

Study Arms (2)

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.

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.

Dietary Supplement: Vitamin C gummy; Dietary Supplement: Vitamin C tablet

Interventions

Vitamin C gummy DIETARY_SUPPLEMENT

vitamin C

Vitamin C gummy, Then Vitamin C Caplet; Vitamin C tablet, Then Vitamin C gummy

Vitamin C tablet DIETARY_SUPPLEMENT

vitamin C

Vitamin C gummy, Then Vitamin C Caplet; Vitamin C tablet, Then Vitamin C gummy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

Church & Dwight Co., Inc.

Princeton, New Jersey, 08543, United States

Location

Related Publications (1)

• 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.

  PMID: 31747355 DERIVED

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. Annahita Ghassemi, PhD
• Organization: Church & Dwight Co., Inc

annahita.ghassemi@churchdwight.com

609-806-1200

Study Officials

• Annahita Ghassemi

  Church & Dwight Company, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 20, 2018
• Study Start: August 1, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: August 23, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)