NCT06471023

A Pharmacokinetic Study of Single Oral Doses of Six Different Vitamin C Product Forms

A Randomized, Crossover, Pharmacokinetic Assessment of Single Oral Doses of Six Different Vitamin C Product Forms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 5.5% 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.

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 0.5, 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, T1/2, 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.

Conditions

• Healthy
• Pharmacokinetic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TP1	Vitamin C formulation 1, 1000 mg
DIETARY_SUPPLEMENT	TP2	Vitamin C formulation 2, 1000 mg
DIETARY_SUPPLEMENT	TP3	Vitamin C formulation 3, 1000 mg
DIETARY_SUPPLEMENT	TP4	regular Vitamin C, 3000 mg
DIETARY_SUPPLEMENT	CP	Vitamin C formulation 4, 1000 mg
DIETARY_SUPPLEMENT	RP	regular Vitamin C, 1000 mg

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-09-16
• Completion: 2024-09-16
• First posted: 2024-06-24
• Last updated: 2025-01-10

Locations

1 site across 1 country: Canada