A Pharmacokinetic Study of Single Oral Doses of Six Different Vitamin C Product Forms
NCT Number: NCT06471023
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy|Pharmacokinetic
Interventions: DIETARY_SUPPLEMENT: TP1|DIETARY_SUPPLEMENT: TP2|DIETARY_SUPPLEMENT: TP3|DIETARY_SUPPLEMENT: TP4|DIETARY_SUPPLEMENT: CP|DIETARY_SUPPLEMENT: RP
Sponsor: DSM Nutritional Products, Inc.
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Sex: ALL
Age: ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2024-09
Locations: Nutrasource Site (Apex Trials), Guelph, Ontario, N1G 0B4, Canada

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.

Primary Outcome Measures: Bioavailability of vitamin C compared between each of the liposomal formulations TP1 and TP2 to the traditional RP, Area under the plasma concentration-time curve over 24 h (AUC0-24) for L-ascorbic acid following single dose administration of TP1 and TP2 and RP., 0-24 hours
Secondary Outcome Measures: Pharmacokinetics (PK) of single doses of six vitamin C formulations, Peak plasma concentration (Cmax), 0-24 hours|Pharmacokinetics (PK) of single doses of six vitamin C formulations, Time to reach Cmax (Tmax), 0-24 hours|Bioavailability of vitamin C compared between six different formulations., AUC0-24 for L-ascorbic acid of six different vitamin C formulations., 0-24 hours|Excretion of vitamin C in urine over a 24 h period compared between six different formulations., L-ascorbic acid excreted in urine over 24 h post-dose and at intervals 0 - 4 h, 4 - 8 h, 8 - 10 h, and 10 - 24 h post-dose, 0-24 hours|Uptake and maintenance of vitamin C in peripheral blood mononuclear cells (PBMCs) between six different formulations., L-ascorbic acid concentration in PBMCs normalized to cell count (10\^8 cells) pre-dose, 8 h, and 24 h post-dose, 0-24 hours
Other Outcome Measures: Pharmacokinetics (PK) of single doses of six vitamin C formulations., Area under the plasma concentration time curve from time of dosing to infinity (AUCinf), 0-24 hours|Pharmacokinetics (PK) of single doses of six vitamin C formulations., Half-life (T1/2), 0-24 hours|Pharmacokinetics (PK) of single doses of six vitamin C formulations., Elimination rate constant (Kel), 0-24 hours|Gastrointestinal tolerability of single doses of six vitamin C formulations., Gastrointestinal symptom questionnaire scores, 0-24 hours|Antioxidant effects of six different vitamin C formulations., Total antioxidant capacity in plasma pre-dose and 24 h post-dose., 0-24 hours|Heart rate, Change from pre-dose to post-dose in heart rate (beats per minute), 0-24 hours|Systolic and diastolic blood pressure, Change from pre-dose to post-dose in blood pressure (mm Hg), 0-24 hours|Incidence of adverse events, Number of participants with adverse events, up to 8 weeks|Whole blood hemoglobin, Change from pre-dose in whole blood hemoglobin (g/dL), 24 hours|Whole blood hematocrit, Change from pre-dose in whole blood hematocrit (%), 24 hours|Whole blood white blood cells, Change from pre-dose in whole blood white blood cells (x10\^3/uL), 24 hours|Whole blood neutrophils, Change from pre-dose in whole blood neutrophils (cells/uL), 24 hours|Whole blood eosinophils, Change from pre-dose in whole blood eosinophils (cells/uL), 24 hours|Whole blood basophils, Change from pre-dose in whole blood basophils (cells/uL), 24 hours|Whole blood lymphocytes, Change from pre-dose in whole blood lymphocytes (cells/uL), 24 hours|Whole blood monocytes, Change from pre-dose in whole blood monocytes (cells/uL), 24 hours|Whole blood mean platelet volume, Change from pre-dose in whole blood mean platelet volume (fL), 24 hours|Whole blood platelet count, Change from pre-dose in whole blood platelet count (x10\^9/L), 24 hours|Whole blood red blood cell count, Change from pre-dose in whole blood red blood cell count (x10\^6/uL), 24 hours|Whole blood red blood cell distribution width, Change from pre-dose in whole blood red blood cell distribution width (%), 24 hours|Whole blood mean corpuscular volume, Change from pre-dose in whole blood mean corpuscular volume (fL), 24 hours|Whole blood mean corpuscular hemoglobin, Change from pre-dose in whole blood mean corpuscular hemoglobin (pg), 24 hours|Whole Blood Mean Corpuscular Hemoglobin Concentration, Change from pre-dose in whole blood mean corpuscular hemoglobin concentration (g/dL), 24 hours|Serum Sodium, Change from pre-dose in serum sodium (mmol/L), 24 hours|Serum Potassium, Change from pre-dose in serum potassium (mmol/L), 24 hours|Serum Chloride, Change from pre-dose in serum chloride (mmol/L), 24 hours|Serum Urea, Change from pre-dose in serum urea (mg/dL), 24 hours|Serum Creatinine, Change from pre-dose in serum creatinine (umol/L), 24 hours|Serum Estimated Glomerular Filtration, Change from pre-dose in serum estimated glomerular filtration rate (mL/min/1.73\^2), 24 hours|Serum Total Protein, Change from pre-dose in serum total protein (g/dL), 24 hours|Serum Albumin, Change from pre-dose in serum albumin (g/dL), 24 hours|Serum Globulin, Change from pre-dose in serum globulin (g/dL), 24 hours|Serum Total Bilirubin, Change from pre-dose in serum total bilirubin (mg/dL), 24 hours|Serum Glucose, Change from pre-dose in serum glucose concentration (mg/dL), 24 hours|Serum Alanine Transaminase, Change from pre-dose in serum alanine transaminase concentration (U/L), 24 hours|Serum Aspartate Transaminase, Change from pre-dose in serum aspartate transaminase concentration (U/L), 24 hours|Serum Alkaline Phosphatase, Change from pre-dose in serum alkaline phosphatase concentration (U/L), 24 hours|Gamma Glutamyl Transferase, Change from pre-dose in serum gamma glutamyl transferase concentration (U/L), 24 hours