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

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.

Conditions

• Healthy
• Pharmacokinetic

Interventions

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

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  collaborator NETWORK

• DSM Nutritional Products, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2024-09-16

Completion

2024-09-16

Countries

• Canada

Study Locations