"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects

Semmelweis University

Status and phase: Completed; Phase 1

Conditions: Vitamin C Deficiency

Treatments: Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02606773

NVP-14C

Details and patient eligibility

About

The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.

Enrollment: 32 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21-65 years old healthy volunteers
• body weight >45 kg
• body height >150 cm
• plasma ascorbic acid at screening <75 µmol/l
• signed written informed consent
• subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days)
• subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit

Exclusion criteria

• confirmed or suspected active infection
• liver or renal failure (equal or greater than CKD3)
• chronic disease that affects absorption or vitamin C metabolism
• severe metabolic disorder
• body mass index >35 kg/m2
• malabsorption syndrome that affects vitamin C metabolism
• heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate
• gastrointestinal bleeding in past three months
• uncontrolled diabetes mellitus (HbA1c>8,5%)
• malignant disease
• alcohol or drug abuse
• active psychiatric disorder, intention for suicidal, disorders with unconsciousness
• psychopathic disorder, lack of cooperation
• known coagulopathy
• chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
• untreated hypertension if blood pressure is greater than 165/95 mmHg
• gravidity or breastfeeding
• taking more than 100 mg vitamin C daily within 2 weeks to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

600 mg Novo C plus

Experimental group

Description:

Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)

Treatment:

Drug: Ascorbic Acid

900 mg Novo C Plus

Experimental group

Description:

Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)

Treatment:

Drug: Ascorbic Acid

500 mg intravenous vitamin C

Active Comparator group

Description:

Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)

Treatment:

Drug: Ascorbic Acid

500 mg oral vitamin C

Active Comparator group

Description:

Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)

Treatment:

Drug: Ascorbic Acid