Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471023
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-12
Brief Title:
A Pharmacokinetic Study of Single Oral Doses of Six Different Vitamin C Product Forms
Sponsor:
DSM Nutritional Products Inc
Organization:
DSM Nutritional Products Inc
Study Overview
Official Title:
A Randomized Crossover Pharmacokinetic Assessment of Single Oral Doses of Six Different Vitamin C Product Forms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vitamin C ascorbic acid is an essential nutrient linked to many aspects of basic human physiology It is a potent antioxidant and involved as a cofactor for many human enzymes and its extreme deficiency can lead to a fatal disease known as scurvy and reduce immune function Relatively less serious deficiency over a longer period of time may also increase cardiovascular disease and cancer risk Deficiency is common amongst the Canadian general population with around 55 being found to possess deficient plasma concentrations Moreover amongst many industrialized countries rates of deficiency can be as high as 15 of the general population Potential vitamin C overdose is not considered to be serious but symptoms can include nausea vomiting headache rash and asthenia
The pharmacokinetic profiles of vitamin C supplements are influenced by their formulation impacting safety and efficacy The study will compare the PK properties of six different vitamin C formulations each over a 24 h test period
The pharmacokinetic profiles of vitamin C supplements are influenced by their formulation impacting safety and efficacy The study will compare the PK properties of six different vitamin C formulations each over a 24 h test period
Detailed Description:
This is a randomized 6-way crossover pharmacokinetic study to assess 6 different vitamin C formulations in healthy adults
There is 1 comparator product CP 1 reference product RP and 4 test products TP TP1 TP2 TP3 TP4
TP1 Vitamin C formulation 1 1000 mg
TP2 Vitamin C formulation 2 1000 mg
TP3 Vitamin C formulation 3 1000 mg
TP4 regular Vitamin C mega dose 3000 mg
CP Vitamin C formulation 4 1000 mg
RP regular Vitamin C 1000 mg
Each sequence will have 9 participants for a total of 27 participants
Sequence 1 TP1 TP2 TP3 TP4 CP RP
Sequence 2 RP TP1 TP2 TP3 TP4 CP
Sequence 3 CP RP TP1 TP2 TP3 TP4
Pharmacokinetic blood sampling will occur pre-dose and at 05 1 2 3 4 6 8 10 and 24 h post dose Blood samples collected will be used to assess the PK profiles of all 6 formulations PK parameters measured will include AUC0-24 Cmax Tmax AUCinf T12 and Kel for L-ascorbic acid L-ascorbic acid concentrations will be measured in urine to compare excretion during 0-4 h 4-8 h 8-10 h and 10-24 h post-dose between all 6 formulations L-ascorbic acid will also be measured in peripheral blood mononuclear cells at 8 h and 24 h post-dose to compare uptake and maintenance between all 6 formulations
Gastrointestinal symptom questionnaire scores and total antioxidant capacity in plasma at 24 hours post-dose will also be compared between all 6 formulations
Safety endpoints will be assessed throughout the study and will include reports of adverse events vital signs and safety laboratory assessments
There is 1 comparator product CP 1 reference product RP and 4 test products TP TP1 TP2 TP3 TP4
TP1 Vitamin C formulation 1 1000 mg
TP2 Vitamin C formulation 2 1000 mg
TP3 Vitamin C formulation 3 1000 mg
TP4 regular Vitamin C mega dose 3000 mg
CP Vitamin C formulation 4 1000 mg
RP regular Vitamin C 1000 mg
Each sequence will have 9 participants for a total of 27 participants
Sequence 1 TP1 TP2 TP3 TP4 CP RP
Sequence 2 RP TP1 TP2 TP3 TP4 CP
Sequence 3 CP RP TP1 TP2 TP3 TP4
Pharmacokinetic blood sampling will occur pre-dose and at 05 1 2 3 4 6 8 10 and 24 h post dose Blood samples collected will be used to assess the PK profiles of all 6 formulations PK parameters measured will include AUC0-24 Cmax Tmax AUCinf T12 and Kel for L-ascorbic acid L-ascorbic acid concentrations will be measured in urine to compare excretion during 0-4 h 4-8 h 8-10 h and 10-24 h post-dose between all 6 formulations L-ascorbic acid will also be measured in peripheral blood mononuclear cells at 8 h and 24 h post-dose to compare uptake and maintenance between all 6 formulations
Gastrointestinal symptom questionnaire scores and total antioxidant capacity in plasma at 24 hours post-dose will also be compared between all 6 formulations
Safety endpoints will be assessed throughout the study and will include reports of adverse events vital signs and safety laboratory assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None