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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02606773
• Date of registration: 13/11/2015
• Prospective Registration: No
• Primary sponsor: Semmelweis University
• Public title: "Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
• Scientific title: Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
• Date of first enrolment: June 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02606773
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Vitamin C Deficiency

Intervention(s)

Drug: Ascorbic Acid

Primary Outcome(s)

Plasma ascorbic acid concentration area under curve [Time Frame: 360 minutes]

Secondary Outcome(s)

Urine ascorbic acid excretion [Time Frame: 12 hours]

Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 24 hours]

Secondary ID(s)

NVP-14C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novonex Pharma Kft