Trial Outcomes & Findings for Bioequivalence Study on Vitamin C in Healthy Adults (NCT NCT03562988)

NCT ID: NCT03562988

Last Updated: 2021-08-23

Results Overview

Mean Plasma L-ascorbic Acid as Total Area Under the Curve \[AUC(0-24 hours)\]

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
• Results posted on: 2021-08-23

Participant Flow

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

Participant milestones

Measure	Vitamin C Gummy, Then Vitamin C Caplet 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 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.
Overall Study STARTED	17	18
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study on Vitamin C in Healthy Adults

Baseline characteristics by cohort

Measure	All Study Participants n=35 Participants All Study Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

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

Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)]

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]	1114.66 μmol*min/L Standard Deviation 236.81	1149.09 μmol*min/L Standard Deviation 237.89

PRIMARY outcome

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

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

Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] for All Study Participants

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]	273.20 nmol*min/10^8 leukocytes Standard Deviation 115.70	297.20 nmol*min/10^8 leukocytes Standard Deviation 105.86

PRIMARY outcome

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

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

Mean Plasma L-ascorbic Acid as Cmax

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Plasma L-ascorbic Acid as Cmax	72.75 μmol/L Standard Deviation 15.74	78.97 μmol/L Standard Deviation 20.51

PRIMARY outcome

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

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

Mean Leukocyte L-ascorbic Acid as Cmax

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Leukocyte L-ascorbic Acid as Cmax	22.96 nmol/10^8 leukocytes Standard Deviation 18.91	22.74 nmol/10^8 leukocytes Standard Deviation 13.98

SECONDARY outcome

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

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

Mean Time of maximum Vitamin C concentration

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Plasma Vitamin C Absorption Rate as Tmax	2.59 hours Standard Deviation 0.71	2.88 hours Standard Deviation 1.11

SECONDARY outcome

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

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

Mean Time of maximum Vitamin C concentration

Outcome measures

Measure	Vitamin C Gummy n=32 Participants A single oral dose of vitamin C gummy	Vitamin C Caplet n=33 Participants A single oral dose of vitamin C caplet
Mean Leucocyte Vitamin C Absorption Rate as Tmax	6.73 hours Standard Deviation 3.61	4.58 hours Standard Deviation 3.84

Adverse Events

Vitamin C Gummy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vitamin C Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin C Gummy n=32 participants at risk；n=35 participants at risk A single oral dose of gummy vitamin C to monitor vitamin C blood levels Vitamin C gummy: vitamin C	Vitamin C Tablet n=33 participants at risk；n=35 participants at risk A single oral dose of tablet vitamin C to monitor vitamin C blood levels Vitamin C tablet: vitamin C
General disorders Mild Somnolence	3.1% 1/32 • Number of events 1 • 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.	0.00% 0/33 • 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.
Gastrointestinal disorders Mild Nausea	0.00% 0/32 • 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.	3.0% 1/33 • Number of events 1 • 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.
Blood and lymphatic system disorders Abnormal Neutrophil Count	3.1% 1/32 • Number of events 1 • 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.	0.00% 0/33 • 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.

Additional Information

Dr. Annahita Ghassemi, PhD

Church & Dwight Co., Inc

Phone: 609-806-1200

Email: annahita.ghassemi@churchdwight.com

Results disclosure agreements

• Principal investigator is a sponsor employee Confidentiality and Master Service Agreement
• Publication restrictions are in place

Restriction type: OTHER